Aortic Stenosis, SevereHOME-TAVINCT07738575
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
A study testing Same-Day Discharge Strategy and Standard-of-Care Discharge Strategy in people with Aortic Stenosis, Severe and Aortic Stenosis, run by Hospital Clinic of Barcelona at 3 sites in 2 countries.
Trial summary
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Severe, Aortic Stenosis
- What is being tested?
- Same-Day Discharge Strategy and Standard-of-Care Discharge Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Sep 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age)
- Severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI
- Treatment with the Medtronic Evolut PRO+, Evolut FX, Evolut FX+, or subsequent iterations
- Successful TAVI procedure according to VARC-3 technical success criteria
- Clinical stability 6 hours after TAVI
- Written informed consent obtained before study participation
Who cannot join
- Inability to ambulate independently at baseline
- Hemodynamic or clinical instability before TAVI
- Urgent or emergent TAVI procedure
- Non-transfemoral access
- Inadequate social support for discharge home
- Inability to understand or comply with post-discharge instructions
Show all 13Show fewer
- Baseline right bundle branch block or high-grade atrioventricular block
- Baseline left ventricular ejection fraction <20%
- Severe chronic kidney disease (estimated glomerular filtration rate : eGFR <30 mL/min/1.73 m² or dialysis).
- Type 2-4 bleeding within 6 hours after TAVI
- New-onset left bundle branch block or high-grade atrioventricular block within 6 hours after TAVI, unless a permanent pacemaker has already been implanted
- New-onset atrial fibrillation within 6 hours after TAVI
- Persistent hemodynamic instability within 6 hours after TAVI
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Emilie Pelletier Beaumont, Msc contact
3 sites in 2 countries
Spain2 sites
Hospital Clínic de Barcelona
Barcelona
Ander Regueiro, Md, PhD, 34 93 227 5400-2035, AREGUEIR@clinic.cat
Hospital Universitario 12 de Octubre
Madrid
Jorge Nuche-Berenguer, Md, PhD, (+34) 619672813, jorge.nuche@salud.madrid.org
Carolina Andrade, (+34) 658 065 843, candrade.imas12@h12o.es
Canada1 site
Institut Universitaire de cardiologie et de pneumologie de Quebec
Québec, Quebec, G1Y 3K4
Josep Rodes-Cabau, Md, PhD, 1-418-656-8711, josep.rodes@criucpq.ulaval.ca
Emilie Pelletier Beaumont, MSc, 1-418-656-8711 ext. 3929, emilie.pelletier-beaumont@criucpq.ulaval.ca
About this study
Official title: HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Preliminary observational studies suggest that same-day discharge after TAVI may be feasible and safe in carefully selected patients, but randomized evidence remains limited, particularly in patients treated with self-expanding valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized controlled trial designed to evaluate whether a same-day discharge strategy is non-inferior to standard hospital discharge after successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Eligible patients who remain clinically stable 6 hours after the procedure will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge.
The primary endpoint is a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include assessment of quality of life, patient-reported experience measures, healthcare resource utilization, and cost-effectiveness.
Read the detailed description
Transcatheter aortic valve implantation (TAVI) has undergone substantial technological and procedural advances, leading to improved procedural safety, widespread adoption of minimalist approaches, and progressive reductions in hospital length of stay. As TAVI expands to lower-risk populations and procedure volumes continue to increase, optimizing post-procedural care pathways has become increasingly important to improve healthcare efficiency while maintaining patient safety.
Same-day discharge has emerged as a potential strategy to reduce healthcare resource utilization, improve patient satisfaction, and lower healthcare costs. Although observational studies have demonstrated the feasibility of same-day discharge in selected patients, robust randomized evidence remains scarce, especially for patients treated with self-expanding transcatheter heart valves.
The HOME-TAVI trial is a prospective, multicenter, international, randomized, controlled, open-label study evaluating a same-day discharge strategy compared with standard hospital discharge in patients undergoing elective transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ transcatheter heart valve system.
Following a successful TAVI procedure and confirmation of clinical stability 6 hours after the intervention, eligible patients will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge. Participants will undergo follow-up assessments at 7 days, 30 days, and 1 year.
The primary objective is to demonstrate that same-day discharge is non-inferior to standard discharge with respect to a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include evaluation of quality of life, patient-reported experience measures, healthcare resource utilization, quality-adjusted life years, and health economic outcomes.
- Conditions
- Aortic Stenosis, Severe, Aortic Stenosis
- Being tested
- Same-Day Discharge Strategy, Standard-of-Care Discharge Strategy
- Keywords
- Transcatheter Aortic Valve Implantation (TAVI), TAVI, TAVR, Same-Day Discharge, Early Discharge, Self-Expanding Valve, Evolut FX, Evolut FX+, Evolut PRO+
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-Day Discharge StrategyOther
Participants are discharged on the same day following successful transfemoral TAVI after confirmation of clinical stability 6 hours after the procedure. The discharge pathway includes standardized clinical assessment, patient and caregiver education, pre-discharge transthoracic echocardiography and blood testing, and a follow-up telephone assessment on the day after discharge.
Standard-of-Care Discharge StrategyOther
Participants receive routine post-procedural inpatient care following successful transfemoral TAVI and are discharged according to standard clinical practice (next-day or later discharge), with follow-up assessments performed according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Same-Day Discharge | Experimental | Participants randomized to the experimental arm will undergo a predefined same-day discharge pathway following successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Patients who remain clinically stable 6 hours after the procedure will be discharged on the same day after completion of the required clinical assessments and discharge education. A follow-up telephone assessment will be performed on the day after the procedure. Receives: Other: Same-Day Discharge Strategy |
| Standard-of-Care Discharge | Active comparator | Participants randomized to the control arm will receive standard inpatient post-procedural care and will be discharged according to local standard clinical practice (next-day or later discharge). Receives: Other: Standard-of-Care Discharge Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission
Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission, defined according to Valve Academic Research Consortium-3 (VARC-3) criteria
Measured: from randomization (6 hours after TAVI) through 30 days after TAVI
Secondary outcomes (20)
Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12)
Change in health-related quality of life measured using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The KCCQ-12 is a disease-specific questionnaire assessing symptoms, physical limitations, social limitations, and quality of life in patients with heart disease. Scores range from 0 to 100, with higher scores indicating better health status and quality of life.
Measured: Baseline and 30 days
Change in health-related quality of life assessed using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L)
Change in health-related quality of life measured using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels. Responses are converted into an EQ-5D-5L index value, with higher values indicating better health status. (If you are reporting the EQ Visual Analogue Scale instead of the index score, the description should instead state that the EQ VAS ranges from 0 to 100, with higher scores indicating better perceived health.)
Measured: Baseline and 30 days
Readiness for Hospital Discharge
Patient-reported readiness for hospital discharge assessed using the Readiness for Hospital Discharge Scale (RHDS) before discharge. The RHDS score ranges from 0 to 10, with higher scores indicating greater readiness for hospital discharge.
Measured: Pre-discharge
Post-discharge care delivery satisfaction
Patient-reported satisfaction with post-discharge care assessed using the Post-Discharge Care Delivery Satisfaction (PDCDS) questionnaire at 7 days after discharge. The PDCDS score ranges from [minimum] to [maximum], with higher scores indicating greater satisfaction with post-discharge care.
Measured: 7 days
Quality-adjusted life years (QALYs)
Quality-adjusted life years (QALYs) calculated by combining survival duration and health utility values derived from the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) questionnaire into a single outcome measure.
Measured: 1 year
All-cause mortality
Incidence of all-cause mortality defined according to Valve Academic Research Consortium 3 (VARC-3) criteria.
Measured: 7 days and 30 days
Type 2-4 bleeding
Incidence of Type 2-4 bleeding events, as defined according to Valve Academic Research Consortium 3 (VARC-3) criteria.
Measured: 7 days and 30 days
Major vascular complications
Incidence of major vascular complications according to Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: 7 days and 30 days
Stroke
Incidence of stroke according to Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: 7 days and 30 days
Cardiovascular hospital readmission
Incidence of cardiovascular hospital readmission during follow-up.
Measured: 7 days and 30 days
Non-cardiovascular hospital readmission
Incidence of non-cardiovascular hospital readmission during follow-up.
Measured: 7 days and 30 days
Permanent pacemaker implantation
Incidence of permanent pacemaker implantation.
Measured: 7 days and 30 days
Acute kidney injury (stage 2-4)
Incidence of acute kidney injury (stage 2-4) according to Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: 7 days and 30 days
New-onset heart failure
Incidence of new-onset heart failure according to Valve Academic Research Consortium-3 (VARC-3) criteria.
Measured: 7 days and 30 days
Hospital length of stay
Total hospital length of stay following the index procedure, measured in days.
Measured: 30 days
Total intensive care unit (ICU) days
Total number of intensive care unit days during the 30-day follow-up period.
Measured: 30 days
Total number of hospital bed-days
Total number of hospital bed-days during the 30-day follow-up period.
Measured: 30 days
Cost-utility analysis
Cost-utility analysis comparing the two treatment strategies, including healthcare costs and health outcomes, over 1 year in the Hospital Clínic de Barcelona cohort
Measured: 1 year
Incremental cost-effectiveness ratio (ICER)
Incremental cost-effectiveness ratio (ICER) comparing the two treatment strategies, expressed as the incremental cost associated with the additional health benefit over 1 year in the Hospital Clínic de Barcelona cohort over 1 year.
Measured: 1 year
Budget impact analysis
Budget impact analysis evaluating the financial consequences of implementing the intervention in the Hospital Clínic de Barcelona cohort over 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 764 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josep Rodes-Cabau, Md, PhD, Study director, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738575
- Sponsor's protocol ID
- HOME-TAVI 2026-4460
- Acronym
- HOME-TAVI
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding IPD sharing has not yet been made. The study will collect individual participant data, including clinical, procedural, imaging, and follow-up data. Following study completion and publication of the primary results, requests for access to de-identified individual participant data from qualified researchers may be considered by the sponsor on a case-by-case basis, subject to ethical, legal, regulatory, and institutional requirements.
Publications
Russo MJ, Okoh AK, Stump K, Smith M, Erinne I, Johannesen J, Chaudhary A, Chiricolo A, Hakeem A, Lemaire A, Lee LY, Chen C. Safety and Feasibility of Same Day Discharge after Transcatheter Aortic Valve Replacement Post COVID-19. Struct Heart. 2021 Mar-Apr;5(2):182-185. doi: 10.1080/24748706.2020.1853861. Epub 2022 Mar 21. No abstract available.
PubMed 35378799Goel A, Malik AH, Bandyopadhyay D, Chakraborty S, Gupta R, Abbott JD, Ahmad H. The 30-Day Readmission Rate of Same-Day Discharge Following Transcatheter Aortic Valve Implantation (from National Readmission Database 2015 to 2019). Am J Cardiol. 2022 Aug 1;176:112-117. doi: 10.1016/j.amjcard.2022.04.033. Epub 2022 May 27.
PubMed 35644697Zahid S, Rai D, Tanveer Ud Din M, Khan MZ, Ullah W, Usman Khan M, Thakkar S, Hussein A, Baibhav B, Rao M, Abtahian F, Bhatt DL, Depta JP. Same-Day Discharge After Transcatheter Aortic Valve Implantation: Insights from the Nationwide Readmission Database 2015 to 2019. J Am Heart Assoc. 2022 Jun 7;11(11):e024746. doi: 10.1161/JAHA.121.024746. Epub 2022 May 27.
PubMed 35621233Cepas-Guillen P, Vidal-Cales P, Gabani R, Espinosa T, Trilla M, Regueiro A. Initial experience of same-day discharge after transcatheter aortic valve implantation. Rev Esp Cardiol (Engl Ed). 2023 Sep;76(9):743-745. doi: 10.1016/j.rec.2023.03.020. Epub 2023 May 16. No abstract available. English, Spanish.
PubMed 37201715Grubb KJ, Gada H, Mittal S, Nazif T, Rodes-Cabau J, Fraser DGW, Lin L, Rovin JD, Khalil R, Sultan I, Gardner B, Lorenz D, Chetcuti SJ, Patel NC, Harvey JE, Mahoney P, Schwartz B, Jafar Z, Wang J, Potluri S, Vora AN, Sanchez C, Corrigan A, Li S, Yakubov SJ. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5):558-570. doi: 10.1016/j.jcin.2023.01.016.
PubMed 36922042Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
PubMed 30883058Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
PubMed 30883053Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
PubMed 34453165Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):450-500. doi: 10.1016/j.jacc.2020.11.035. Epub 2020 Dec 17.
PubMed 33342587
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial
- ClinicalTrials.gov ID
- NCT07738575
- Acronym / sponsor ID
- HOME-TAVI / HOME-TAVI 2026-4460
- Conditions
- Aortic Stenosis, Severe, Aortic Stenosis
- Keywords
- Transcatheter Aortic Valve Implantation (TAVI), TAVI, TAVR, Same-Day Discharge, Early Discharge, Self-Expanding Valve, Evolut FX, Evolut FX+
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 764 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Preliminary observational studies suggest that same-day discharge after TAVI may be feasible and safe in carefully selected patients, but randomized evidence remains limited, particularly in patients treated with self-expanding valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized controlled trial designed to evaluate whether a same-day discharge strategy is non-inferior to standard hospital discharge after successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Eligible patients who remain clinically stable 6 hours after the procedure will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge.
The primary endpoint is a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include assessment of quality of life, patient-reported experience measures, healthcare resource utilization, and cost-effectiveness.
Detailed description
Transcatheter aortic valve implantation (TAVI) has undergone substantial technological and procedural advances, leading to improved procedural safety, widespread adoption of minimalist approaches, and progressive reductions in hospital length of stay. As TAVI expands to lower-risk populations and procedure volumes continue to increase, optimizing post-procedural care pathways has become increasingly important to improve healthcare efficiency while maintaining patient safety.
Same-day discharge has emerged as a potential strategy to reduce healthcare resource utilization, improve patient satisfaction, and lower healthcare costs. Although observational studies have demonstrated the feasibility of same-day discharge in selected patients, robust randomized evidence remains scarce, especially for patients treated with self-expanding transcatheter heart valves.
The HOME-TAVI trial is a prospective, multicenter, international, randomized, controlled, open-label study evaluating a same-day discharge strategy compared with standard hospital discharge in patients undergoing elective transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ transcatheter heart valve system.
Following a successful TAVI procedure and confirmation of clinical stability 6 hours after the intervention, eligible patients will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge. Participants will undergo follow-up assessments at 7 days, 30 days, and 1 year.
The primary objective is to demonstrate that same-day discharge is non-inferior to standard discharge with respect to a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include evaluation of quality of life, patient-reported experience measures, healthcare resource utilization, quality-adjusted life years, and health economic outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same-Day Discharge | Experimental | Other: Same-Day Discharge StrategyParticipants randomized to the experimental arm will undergo a predefined same-day discharge pathway following successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Patients who remain clinically stable 6 hours after the procedure will be discharged on the same day after completion of the required clinical assessments and discharge education. A follow-up telephone assessment will be performed on the day after the procedure. |
| Standard-of-Care Discharge | Active comparator | Other: Standard-of-Care Discharge StrategyParticipants randomized to the control arm will receive standard inpatient post-procedural care and will be discharged according to local standard clinical practice (next-day or later discharge). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥18 years of age)
- Severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI
- Treatment with the Medtronic Evolut PRO+, Evolut FX, Evolut FX+, or subsequent iterations
- Successful TAVI procedure according to VARC-3 technical success criteria
- Clinical stability 6 hours after TAVI
Key exclusion criteria (13 listed)
- Inability to ambulate independently at baseline
- Hemodynamic or clinical instability before TAVI
- Urgent or emergent TAVI procedure
- Non-transfemoral access
- Inadequate social support for discharge home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same-Day Discharge StrategyParticipants are discharged on the same day following successful transfemoral TAVI after confirmation of clinical stability 6 hours after the procedure. The discharge pathway includes standardized clinical assessment, patient and caregiver education, pre-discharge transthoracic echocardiography and blood testing, and a follow-up telephone assessment on the day after discharge. | Other | Same-Day Discharge |
| Standard-of-Care Discharge StrategyParticipants receive routine post-procedural inpatient care following successful transfemoral TAVI and are discharged according to standard clinical practice (next-day or later discharge), with follow-up assessments performed according to the study protocol. | Other | Standard-of-Care Discharge |
Primary outcome
Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission
Time frame: from randomization (6 hours after TAVI) through 30 days after TAVI
Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission, defined according to Valve Academic Research Consortium-3 (VARC-3) criteria
20 secondary outcomes
Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12)
Time frame: Baseline and 30 days
Change in health-related quality of life assessed using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: Baseline and 30 days
Readiness for Hospital Discharge
Time frame: Pre-discharge
Post-discharge care delivery satisfaction
Time frame: 7 days
Quality-adjusted life years (QALYs)
Time frame: 1 year
All-cause mortality
Time frame: 7 days and 30 days
Type 2-4 bleeding
Time frame: 7 days and 30 days
Major vascular complications
Time frame: 7 days and 30 days
Stroke
Time frame: 7 days and 30 days
Cardiovascular hospital readmission
Time frame: 7 days and 30 days
Non-cardiovascular hospital readmission
Time frame: 7 days and 30 days
Permanent pacemaker implantation
Time frame: 7 days and 30 days
Acute kidney injury (stage 2-4)
Time frame: 7 days and 30 days
New-onset heart failure
Time frame: 7 days and 30 days
Hospital length of stay
Time frame: 30 days
Total intensive care unit (ICU) days
Time frame: 30 days
Total number of hospital bed-days
Time frame: 30 days
Cost-utility analysis
Time frame: 1 year
Incremental cost-effectiveness ratio (ICER)
Time frame: 1 year
Budget impact analysis
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 35378799Russo MJ, Okoh AK, Stump K, Smith M, Erinne I, Johannesen J, Chaudhary A, Chiricolo A, Hakeem A, Lemaire A, Lee LY, Chen C. Safety and Feasibility of Same Day Discharge after Transcatheter Aortic Valve Replacement Post COVID-19. Struct Heart. 2021 Mar-Apr;5(2):182-185. doi: 10.1080/24748706.2020.1853861. Epub 2022 Mar 21. No abstract available.
- Background: PubMed 35644697Goel A, Malik AH, Bandyopadhyay D, Chakraborty S, Gupta R, Abbott JD, Ahmad H. The 30-Day Readmission Rate of Same-Day Discharge Following Transcatheter Aortic Valve Implantation (from National Readmission Database 2015 to 2019). Am J Cardiol. 2022 Aug 1;176:112-117. doi: 10.1016/j.amjcard.2022.04.033. Epub 2022 May 27.
- Background: PubMed 35621233Zahid S, Rai D, Tanveer Ud Din M, Khan MZ, Ullah W, Usman Khan M, Thakkar S, Hussein A, Baibhav B, Rao M, Abtahian F, Bhatt DL, Depta JP. Same-Day Discharge After Transcatheter Aortic Valve Implantation: Insights from the Nationwide Readmission Database 2015 to 2019. J Am Heart Assoc. 2022 Jun 7;11(11):e024746. doi: 10.1161/JAHA.121.024746. Epub 2022 May 27.
- Background: PubMed 37201715Cepas-Guillen P, Vidal-Cales P, Gabani R, Espinosa T, Trilla M, Regueiro A. Initial experience of same-day discharge after transcatheter aortic valve implantation. Rev Esp Cardiol (Engl Ed). 2023 Sep;76(9):743-745. doi: 10.1016/j.rec.2023.03.020. Epub 2023 May 16. No abstract available. English, Spanish.
- Background: PubMed 36922042Grubb KJ, Gada H, Mittal S, Nazif T, Rodes-Cabau J, Fraser DGW, Lin L, Rovin JD, Khalil R, Sultan I, Gardner B, Lorenz D, Chetcuti SJ, Patel NC, Harvey JE, Mahoney P, Schwartz B, Jafar Z, Wang J, Potluri S, Vora AN, Sanchez C, Corrigan A, Li S, Yakubov SJ. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5):558-570. doi: 10.1016/j.jcin.2023.01.016.
- Background: PubMed 30883058Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
- Background: PubMed 30883053Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
- Background: PubMed 34453165Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
- Background: PubMed 33342587Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):450-500. doi: 10.1016/j.jacc.2020.11.035. Epub 2020 Dec 17.
- Individual participant dataSharing planned: Undecided. A decision regarding IPD sharing has not yet been made. The study will collect individual participant data, including clinical, procedural, imaging, and follow-up data. Following study completion and publication of the primary results, requests for access to de-identified individual participant data from qualified researchers may be considered by the sponsor on a case-by-case basis, subject to ethical, legal, regulatory, and institutional requirements.
Related trials for Aortic Stenosis, Severe
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruiting
Effect of Double-Tap Optimization on Valve Expansion and Hemodynamics in Balloon-expandable Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial (DO-OPT TAVI Trial)
Severe Aortic Stenosis
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilie Pelletier Beaumont, Msc contact
Josep Rodes-Cabau, Md, PhD study director
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same-Day Discharge Strategy and Standard-of-Care Discharge Strategy in people with Aortic Stenosis, Severe and Aortic Stenosis, run by Hospital Clinic of Barcelona at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ander Regueiro, MD (+34932275400 ext. 5519, AREGUEIR@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission (time frame: from randomization (6 hours after TAVI) through 30 days after TAVI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07738575, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.