Aortic Valve DiseaseFAST TRACKNCT05758909
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
An observational study of Aortic Valve Disease and Aortic Valve Stenosis, run by Fundación EPIC at 13 sites in Spain.
Trial summary
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis, Heart Valve Diseases
- What is being tested?
- TF TAVI
- Type of treatment
- Medical device
- How many people
- 585 participants
- Where
- 13 sitesSpain
- Study dates
- 4 Apr 2023to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients undergoing scheduled transfemoral TAVI implantation, performed on an outpatient basis
Who may be able to join
- Patients who meet all of the following conditions will be included:
- Patients ≥ 18 years undergoing transfemoral TAVI implantation scheduled, performed on an outpatient basis.
- Patients with percutaneous implant.
- Patients undergoing the procedure under superficial sedation or Local anesthesia.
- Patients with baseline narrow QRS that does not change after implantation, or definitive pacemaker carrier.
- Patients who have signed the informed consent.
Who cannot join
- Patients who do not meet any of the following conditions:
- Patients with a wide QRS (greater than or equal to 120 msec) at baseline, with the except for patients with permanent pacemakers.
- Hospitalized patients undergoing urgent TAVI implantation.
- Patients with access other than percutaneous transfemoral.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital Universitario A Coruña
A Coruña, 15006
Hospital General Universitario Dr. Balmis
Alicante, 03010
Hospital Clinico San Carlos
Aravaca, 28040
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
Hospital de Santa Creu I Sant Pau
Barcelona, 08025
Hospital Universitari Vall Hebron
Barcelona, 08035
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital Regional Universitario de Malaga
Málaga, 29010
Hospital Universitario Central de Asturias
Oviedo, 33011
Hospital Universitario de Navarra
Pamplona, 31008
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Universitari i Politècnic la Fe
Valencia, 46026
About this study
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
Read the detailed description
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
- Being tested
- TF TAVI
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF TAVIDevice
Follow-up Observation of patients having received a TF-TAVI
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving transfemoral (TF) TAVI | TF TAVI Receives: Device: TF TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of early safety
Proportion of patients with early safety defined as:
- Cardiovascular death.
- Stroke.
- Myocardial Infarction.
- Hospitalization for any reason .
- Major vascular complications.
- Need for pacemakers.
Measured: 30 days
Secondary outcomes (15)
Assessment of Cardiovascular death
Assessment of Cardiovascular death
Measured: 30 days
Assessment of Cardiovascular death
Assessment of Cardiovascular death
Measured: 12 months
Assessment of Stroke
Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria
Measured: 30 days
Assessment of Stroke
Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria
Measured: 12 months
Assessment of Myocardial Infarction
Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria
Measured: 30 days
Assessment of Myocardial Infarction
Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria
Measured: 12 months
Assessment of Hospitalization for any reason
Incidence of patients with Hospitalization for any reason according to VARC 3 criteria
Measured: 30 days
Assessment of Hospitalization for any reason
Incidence of patients with Hospitalization for any reason according to VARC 3 criteria
Measured: 12 months
Assessments of Major Vascular Complications
Incidence of patients with Major Vascular Complications according to VARC 3 criteria
Measured: 30 days
Assessments of Major Vascular Complications
Incidence of patients with Major Vascular Complications according to VARC 3 criteria
Measured: 12 months
Assessments of need for pacemakers
Incidence of patients with need for pacemakers according to VARC 3 criteria
Measured: 30 days
Assessments of need for pacemakers
Incidence of patients with need for pacemakers according to VARC 3 criteria
Measured: 12 months
Assessment of hospitalization time
Incidence of patients with hospitalization according to VARC 3 criteria
Measured: at discharge
Assessment of hospitalization due cardiac reasons
Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria
Measured: 12 months
Assessment of hospitalization due cardiac reasons
Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start4 Apr 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 585 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758909
- Sponsor's protocol ID
- EPIC19-FAST TRACK
- Acronym
- FAST TRACK
- Status last verified
- Dec 2025
- First submitted
- 5 Feb 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barbanti M, van Mourik MS, Spence MS, Iacovelli F, Martinelli GL, Muir DF, Saia F, Bortone AS, Densem CG, van der Kley F, Bramlage P, Vis M, Tamburino C. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention. 2019 Jun 20;15(2):147-154. doi: 10.4244/EIJ-D-18-01197.
PubMed 30777842van Gils L, Baart S, Kroon H, Rahhab Z, El Faquir N, Rodriguez Olivares R, Aga Y, Maugenest AM, Theuns DA, Boersma E, Szili Torok T, De Jaegere PP, Van Mieghem NM. Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study. Europace. 2018 Dec 1;20(12):1981-1988. doi: 10.1093/europace/euy074.
PubMed 29688322Aldalati O, Keshavarzi F, Kaura A, Byrne J, Eskandari M, Deshpande R, Monaghan M, Wendler O, Dworakowski R, MacCarthy P. Factors associated with safe early discharge after transcatheter aortic valve implantation. Cardiol J. 2018;25(1):14-23. doi: 10.5603/CJ.a2017.0087. Epub 2017 Jul 17.
PubMed 28714522Serletis-Bizios A, Durand E, Cellier G, Tron C, Bauer F, Glinel B, Dacher JN, Cribier A, Eltchaninoff H. A Prospective Analysis of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation. Am J Cardiol. 2016 Sep 15;118(6):866-872. doi: 10.1016/j.amjcard.2016.06.035. Epub 2016 Jun 27.
PubMed 27453514Chandrasekhar J, Mehran R. Same or next day discharge: A new chapter in transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2016 Jan 1;87(1):143-4. doi: 10.1002/ccd.26388.
PubMed 27410958Wood DA, Lauck SB, Cairns JA, Humphries KH, Cook R, Welsh R, Leipsic J, Genereux P, Moss R, Jue J, Blanke P, Cheung A, Ye J, Dvir D, Umedaly H, Klein R, Rondi K, Poulter R, Stub D, Barbanti M, Fahmy P, Htun N, Murdoch D, Prakash R, Barker M, Nickel K, Thakkar J, Sathananthan J, Tyrell B, Al-Qoofi F, Velianou JL, Natarajan MK, Wijeysundera HC, Radhakrishnan S, Horlick E, Osten M, Buller C, Peterson M, Asgar A, Palisaitis D, Masson JB, Kodali S, Nazif T, Thourani V, Babaliaros VC, Cohen DJ, Park JE, Leon MB, Webb JG. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):459-469. doi: 10.1016/j.jcin.2018.12.020.
PubMed 30846085
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
- ClinicalTrials.gov ID
- NCT05758909
- Acronym / sponsor ID
- FAST TRACK / EPIC19-FAST TRACK
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 585 participants (estimated)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Mar 2023 (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.
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
Detailed description
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving transfemoral (TF) TAVI | – | Device: TF TAVITF TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing scheduled transfemoral TAVI implantation, performed on an outpatient basis
Key inclusion criteria (6 listed)
- Patients ≥ 18 years undergoing transfemoral TAVI implantation scheduled, performed on an outpatient basis.
- Patients with percutaneous implant.
- Patients undergoing the procedure under superficial sedation or Local anesthesia.
- Patients with baseline narrow QRS that does not change after implantation, or definitive pacemaker carrier.
- Patients who have signed the informed consent.
Key exclusion criteria (4 listed)
- Patients with a wide QRS (greater than or equal to 120 msec) at baseline, with the except for patients with permanent pacemakers.
- Hospitalized patients undergoing urgent TAVI implantation.
- Patients with access other than percutaneous transfemoral.
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 |
|---|---|---|
| TF TAVIFollow-up Observation of patients having received a TF-TAVI | Device | Patients receiving transfemoral (TF) TAVI |
Primary outcome
Assessment of early safety
Time frame: 30 days
Proportion of patients with early safety defined as: * Cardiovascular death. * Stroke. * Myocardial Infarction. * Hospitalization for any reason . * Major vascular complications. * Need for pacemakers.
15 secondary outcomes
Assessment of Cardiovascular death
Time frame: 30 days
Assessment of Cardiovascular death
Time frame: 12 months
Assessment of Stroke
Time frame: 30 days
Assessment of Stroke
Time frame: 12 months
Assessment of Myocardial Infarction
Time frame: 30 days
Assessment of Myocardial Infarction
Time frame: 12 months
Assessment of Hospitalization for any reason
Time frame: 30 days
Assessment of Hospitalization for any reason
Time frame: 12 months
Assessments of Major Vascular Complications
Time frame: 30 days
Assessments of Major Vascular Complications
Time frame: 12 months
Assessments of need for pacemakers
Time frame: 30 days
Assessments of need for pacemakers
Time frame: 12 months
Assessment of hospitalization time
Time frame: at discharge
Assessment of hospitalization due cardiac reasons
Time frame: 12 months
Assessment of hospitalization due cardiac reasons
Time frame: 30 days
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 19 Dec 2025.
- Background: PubMed 30777842Barbanti M, van Mourik MS, Spence MS, Iacovelli F, Martinelli GL, Muir DF, Saia F, Bortone AS, Densem CG, van der Kley F, Bramlage P, Vis M, Tamburino C. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention. 2019 Jun 20;15(2):147-154. doi: 10.4244/EIJ-D-18-01197.
- Background: PubMed 29688322van Gils L, Baart S, Kroon H, Rahhab Z, El Faquir N, Rodriguez Olivares R, Aga Y, Maugenest AM, Theuns DA, Boersma E, Szili Torok T, De Jaegere PP, Van Mieghem NM. Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study. Europace. 2018 Dec 1;20(12):1981-1988. doi: 10.1093/europace/euy074.
- Background: PubMed 28714522Aldalati O, Keshavarzi F, Kaura A, Byrne J, Eskandari M, Deshpande R, Monaghan M, Wendler O, Dworakowski R, MacCarthy P. Factors associated with safe early discharge after transcatheter aortic valve implantation. Cardiol J. 2018;25(1):14-23. doi: 10.5603/CJ.a2017.0087. Epub 2017 Jul 17.
- Background: PubMed 27453514Serletis-Bizios A, Durand E, Cellier G, Tron C, Bauer F, Glinel B, Dacher JN, Cribier A, Eltchaninoff H. A Prospective Analysis of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation. Am J Cardiol. 2016 Sep 15;118(6):866-872. doi: 10.1016/j.amjcard.2016.06.035. Epub 2016 Jun 27.
- Background: PubMed 27410958Chandrasekhar J, Mehran R. Same or next day discharge: A new chapter in transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2016 Jan 1;87(1):143-4. doi: 10.1002/ccd.26388.
- Background: PubMed 30846085Wood DA, Lauck SB, Cairns JA, Humphries KH, Cook R, Welsh R, Leipsic J, Genereux P, Moss R, Jue J, Blanke P, Cheung A, Ye J, Dvir D, Umedaly H, Klein R, Rondi K, Poulter R, Stub D, Barbanti M, Fahmy P, Htun N, Murdoch D, Prakash R, Barker M, Nickel K, Thakkar J, Sathananthan J, Tyrell B, Al-Qoofi F, Velianou JL, Natarajan MK, Wijeysundera HC, Radhakrishnan S, Horlick E, Osten M, Buller C, Peterson M, Asgar A, Palisaitis D, Masson JB, Kodali S, Nazif T, Thourani V, Babaliaros VC, Cohen DJ, Park JE, Leon MB, Webb JG. The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):459-469. doi: 10.1016/j.jcin.2018.12.020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Aortic Valve Stenosis, run by Fundación EPIC at 13 sites in Spain.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of early safety (time frame: 30 days). 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 NCT05758909, which also lists 6 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 19 Dec 2025.