Aortic StenosisNCT05235555
EffecTAVI Registry
An observational study of Aortic Stenosis and Transcatheter Aortic Valve Replacement, run by Federico II University at 1 site in Italy.
Trial summary
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI
- What is being tested?
- Transcatheter heart valve (THV) with CE approval
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2015to 1 Jan 2030
- How long will I take part?
- 10 Years
- 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 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to the current guidelines.
Who may be able to join
- Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation;
- Ability to provide informed consent.
Who cannot join
- Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis;
- Poor adherence to scheduled follow-up;
- Unable to understand and follow study-related instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Federico II University of Naples
Naples, 80131
Anna Franzone, MD,PhD, 0817464325 ext. 0039, anna.franzone@unina.it
MD, PhD, 0817464325 ext. 0039, anna.franzone@unina.it
About this study
Official title: Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.
For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI. Furthermore, newer generations of transcatheter heart valve (THV) design, better patient selection, and technical enhancements have driven improvement in safety and reduction of procedural complications over time.
This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.
Read the detailed description
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.
For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI.
This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.
EffectTAVI is an observational, monocentric registry promoted by Department of Advanced Biomedical Sciences of University of Naples Federico II.
The aim is to collect clinical, procedural, echocardiographic data and to evaluate the clinical outcomes of TAVI procedure.
Study population: consecutive patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to current guidelines recommendations.
Severe AS will be defined according to the following echocardiographic criteria:
- Aortic valve area: < 1 cm2
- Indexed aortic valve area: < 0,6 cm2/m2
- Mean aortic valve gradient: ≥ 40 mmHg
- Peak aortic jet velocity: ≥ 4,0 m/sec
TAVI can be performed using several arterial access: transfemoral, transapical, trans-subclavian and trans-aortic.
Written informed consent will be obtained for all patients for participation in this registry.
After hospital discharge, clinical follow-up will be performed at 30-day, 6 months and 1-year after TAVI. All adverse events were systematically collected and classified according to the definitions of the Valve Academic Research Consortium (VARC)-3 criteria.
Clinical, procedural and follow-up data will be anonymously entered in a web-based database RedCap (https://www.redcap.unina.it/redcap/). Patients will be entered with a pseudonym generated by the data collection system.
The pseudonym does not allow the identification of the patient and, therefore, meets the European criteria for the acquisition of data online.
The access to the online database is allowed through the use of a personal password, provided to the Primary Investigator and to the Co-Investigators involved in the study.
Data analysis will be performed by the investigators of the Department of Advanced Biomedical Sciences.
The extensive case studies that investigators expect to collect will be useful to establish clinical, procedural and follow-up data in short, medium and long term of patients with severe aortic stenosis undergoing TAVI.
- Being tested
- Transcatheter heart valve (THV) with CE approval
- Keywords
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI
- 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.
Transcatheter heart valve (THV) with CE approvalDevice
TAVI trough femoral access or alternative routes
| Study group | Role | What they receive |
|---|---|---|
| Patients with symptomatic severe AS undergoing TAVI. | Not described Receives: Device: Transcatheter heart valve (THV) with CE approval |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
All cause mortality
Measured: 30 days
All cause mortality
All cause mortality
Measured: 1 year
Secondary outcomes (26)
Cardiovascular mortality
Cardiovascular mortality
Measured: 30 days
Cardiovascular mortality
Cardiovascular mortality
Measured: 1 year
Number of participants with neurological events
Neurological events
Measured: 30 days
Number of participants with neurological events
Neurological events
Measured: 1 year
Number of participants with bleeding events
Bleeding events
Measured: 30 days
Number of participants with bleeding events
Bleeding events
Measured: 1 year
Vascular and access-related complications
Vascular and access-related complications
Measured: 30 days
Vascular and access-related complications
Vascular and access-related complications
Measured: 1 year
Number of participants with new conduction disturbances and arrhythmias
New conduction disturbances and arrhythmias
Measured: 30 days
Number of participants with new conduction disturbances and arrhythmias
New conduction disturbances and arrhythmias
Measured: 1 year
Number of participants with acute kidney injury
Acute kidney injury
Measured: 30 days
Number of participants with acute kidney injury
Acute kidney injury
Measured: 1 year
Number of participants with myocardial infarction
Myocardial infarction
Measured: 30 days
Number of participants with myocardial infarction
Myocardial infarction
Measured: 1 year
Hospitalization or re-hospitalization
Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.
Measured: 30 days
Hospitalization or re-hospitalization
Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.
Measured: 1 year
Cardiac structural complications
Any cardiac structure occurring during the procedure involving the aortic annulus, left ventricle outflow tract, ventricular septum, left or right ventricle, left or right atrium, mitral valve apparatus, tricuspid valve apparatus, coronary sinus, and pericardial effusion.
Measured: 30 days
Cardiac structural complications
Any cardiac structure occurring during the procedure involving the aortic annulus, left ventricle outflow tract, ventricular septum, left or right ventricle, left or right atrium, mitral valve apparatus, tricuspid valve apparatus, coronary sinus, and pericardial effusion.
Measured: 1 year
Number of participants with bioprosthetic valve dysfunction
Bioprosthetic valve dysfunction
Measured: 30 days
Number of participants with bioprosthetic valve dysfunction
Bioprosthetic valve dysfunction
Measured: 1 year
Number of participants with leaflet thickening
Hypo-attenuated leaflet thickening (HALT)
Measured: 30 days
Number of participants with leaflet thickening
Hypo-attenuated leaflet thickening (HALT)
Measured: 1 year
Number of participants with leaflet reduced motion
Reduced leaflet motion (RLM)
Measured: 30 days
Number of participants with leaflet reduced motion
Reduced leaflet motion (RLM)
Measured: 1 year
Number of participants with clinically significant valve thrombosis
Clinically significant valve thrombosis
Measured: 30 days
Number of participants with clinically significant valve thrombosis
Clinically significant valve thrombosis
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 posted11 Feb 2022
- Study start1 Sep 2015
- Primary completion9 Sep 2021
- Study completion1 Jan 2030 (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 StenosisStudies 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Esposito, Federico II University
- Investigators
- Giovanni Esposito, MD, PhD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235555
- Sponsor's protocol ID
- 231/18
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17.
PubMed 33332149Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, Alu MC, Madhavan MV, Chau KH, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Blanke P, Leipsic JA, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Herrmann HC, Szeto WY, Genereux P, Pershad A, Lu M, Webb JG, Smith CR, Pibarot P; PARTNER 3 Investigators. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021 Mar 9;77(9):1149-1161. doi: 10.1016/j.jacc.2020.12.052.
PubMed 33663731Popma 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 30883053Mack 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 30883058VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
PubMed 33871579
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry
- ClinicalTrials.gov ID
- NCT05235555
- Acronym / sponsor ID
- 231/18
- Keywords
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 11 Feb 2022 (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.
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.
For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI. Furthermore, newer generations of transcatheter heart valve (THV) design, better patient selection, and technical enhancements have driven improvement in safety and reduction of procedural complications over time.
This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.
Detailed description
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.
For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI.
This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.
EffectTAVI is an observational, monocentric registry promoted by Department of Advanced Biomedical Sciences of University of Naples Federico II.
The aim is to collect clinical, procedural, echocardiographic data and to evaluate the clinical outcomes of TAVI procedure.
Study population: consecutive patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to current guidelines recommendations.
Severe AS will be defined according to the following echocardiographic criteria:
- Aortic valve area: < 1 cm2
- Indexed aortic valve area: < 0,6 cm2/m2
- Mean aortic valve gradient: ≥ 40 mmHg
- Peak aortic jet velocity: ≥ 4,0 m/sec
TAVI can be performed using several arterial access: transfemoral, transapical, trans-subclavian and trans-aortic.
Written informed consent will be obtained for all patients for participation in this registry.
After hospital discharge, clinical follow-up will be performed at 30-day, 6 months and 1-year after TAVI. All adverse events were systematically collected and classified according to the definitions of the Valve Academic Research Consortium (VARC)-3 criteria.
Clinical, procedural and follow-up data will be anonymously entered in a web-based database RedCap (https://www.redcap.unina.it/redcap/). Patients will be entered with a pseudonym generated by the data collection system.
The pseudonym does not allow the identification of the patient and, therefore, meets the European criteria for the acquisition of data online.
The access to the online database is allowed through the use of a personal password, provided to the Primary Investigator and to the Co-Investigators involved in the study.
Data analysis will be performed by the investigators of the Department of Advanced Biomedical Sciences.
The extensive case studies that investigators expect to collect will be useful to establish clinical, procedural and follow-up data in short, medium and long term of patients with severe aortic stenosis undergoing TAVI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic severe AS undergoing TAVI. | – | Device: Transcatheter heart valve (THV) with CE approval |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to the current guidelines.
Key inclusion criteria (2 listed)
- Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation;
- Ability to provide informed consent.
Key exclusion criteria (3 listed)
- Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis;
- Poor adherence to scheduled follow-up;
- Unable to understand and follow study-related instructions.
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 |
|---|---|---|
| Transcatheter heart valve (THV) with CE approvalTAVI trough femoral access or alternative routes | Device | Patients with symptomatic severe AS undergoing TAVI. |
Primary outcome
All cause mortality
Time frame: 30 days
All cause mortality
All cause mortality
Time frame: 1 year
All cause mortality
26 secondary outcomes
Cardiovascular mortality
Time frame: 30 days
Cardiovascular mortality
Time frame: 1 year
Number of participants with neurological events
Time frame: 30 days
Number of participants with neurological events
Time frame: 1 year
Number of participants with bleeding events
Time frame: 30 days
Number of participants with bleeding events
Time frame: 1 year
Vascular and access-related complications
Time frame: 30 days
Vascular and access-related complications
Time frame: 1 year
Number of participants with new conduction disturbances and arrhythmias
Time frame: 30 days
Number of participants with new conduction disturbances and arrhythmias
Time frame: 1 year
Number of participants with acute kidney injury
Time frame: 30 days
Number of participants with acute kidney injury
Time frame: 1 year
Number of participants with myocardial infarction
Time frame: 30 days
Number of participants with myocardial infarction
Time frame: 1 year
Hospitalization or re-hospitalization
Time frame: 30 days
Hospitalization or re-hospitalization
Time frame: 1 year
Cardiac structural complications
Time frame: 30 days
Cardiac structural complications
Time frame: 1 year
Number of participants with bioprosthetic valve dysfunction
Time frame: 30 days
Number of participants with bioprosthetic valve dysfunction
Time frame: 1 year
Number of participants with leaflet thickening
Time frame: 30 days
Number of participants with leaflet thickening
Time frame: 1 year
Number of participants with leaflet reduced motion
Time frame: 30 days
Number of participants with leaflet reduced motion
Time frame: 1 year
Number of participants with clinically significant valve thrombosis
Time frame: 30 days
Number of participants with clinically significant valve thrombosis
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 23 Feb 2024.
- Background: PubMed 33332149Otto 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. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Background: PubMed 33663731Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, Alu MC, Madhavan MV, Chau KH, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Blanke P, Leipsic JA, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Herrmann HC, Szeto WY, Genereux P, Pershad A, Lu M, Webb JG, Smith CR, Pibarot P; PARTNER 3 Investigators. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021 Mar 9;77(9):1149-1161. doi: 10.1016/j.jacc.2020.12.052.
- 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 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 33871579VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
- Individual participant dataSharing planned: No
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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.
Giovanni Esposito, MD, PhD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Transcatheter Aortic Valve Replacement, run by Federico II University at 1 site in Italy.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Giovanni Esposito, MD, PhD (+390817463075, espogiov@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT05235555, 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 23 Feb 2024.