Aortic StenosisMASTER-TAVI IINCT07623083
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
An observational study of Aortic Stenosis and Mitral Regurgitation, run by Josep Rodes-Cabau.
Trial summary
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2026to 5 Jun 2034
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) who also present with significant concomitant mitral regurgitation and/or tricuspid regurgitation. The study will mainly include elderly patients and patients considered at intermediate, high, or prohibitive surgical risk for conventional open-heart surgery. Eligible participants will have moderate-to-severe or severe mitral and/or tricuspid valve regurgitation identified by echocardiography before TAVI. Patients will be evaluated and treated according to a staged transcatheter treatment algorithm based on current clinical guidelines and the evolution of valve disease following TAVI.
Who may be able to join
- Age >18 years.
- Patients with severe AS undergoing transarterial TAVI.
- Concomitant significant MR and/or TR (≥3+).
Who cannot join
- Life expectancy <1 year due to noncardiac conditions.
- Any prior mitral or tricuspid valve surgery.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Active endocarditis.
- Subjects in whom transesophageal echocardiography is contraindicated or high risk.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.
Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.
Read more
In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.
This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.
The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.
The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.
The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- Aortic stenosis, Transcatheter aortic valve implantation (TAVI), Multivalvular heart disease, Mitral regurgitation, Tricuspid regurgitation, Structural heart disease, Valve disease management algorithm
- Medical subject headings
- Aortic Valve Stenosis, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Concomitant isolated MR - 3+ or 4 | Patients with severe aortic stenosis (AS) and significant mitral regurgitation (MR) undergoing TAVI followed, if needed, by mitral intervention (M-TEER). | |
| Concomitant isolated TR - 3+ to 5 | Patients with severe AS and significant tricuspid regurgitation (TR) undergoing TAVI followed, if needed, by tricuspid intervention (T-TEER). | |
| Concomitant MR and TR | Patients with severe AS, MR, and TR undergoing staged triple-valve transcatheter therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality or re-hospitalization for worsening heart failure
Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure
Measured: Minimum of 1 year
Secondary outcomes (36)
All-cause mortality or re-hospitalization for worsening heart failure
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.
Measured: 1 Year
All-cause mortality or re-hospitalization for worsening heart failure
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 2-year follow-up
Measured: 2 year
All-cause mortality or re-hospitalization for worsening heart failure
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 3-year follow-up.
Measured: 3 year
All-cause mortality or re-hospitalization for worsening heart failure
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 4-year follow-up.
Measured: 4 year
All-cause mortality or re-hospitalization for worsening heart failure
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 5-year follow-up.
Measured: 5 year
All-cause mortality
All-cause mortality at 1 year
Measured: 1 year
All-cause mortality
All-cause mortality at 2 year
Measured: 2 year
All-cause mortality
All-cause mortality at 3 year
Measured: 3 year
All-cause mortality
All-cause mortality at 4 year
Measured: 4 year
All-cause mortality
All-cause mortality at 5 year
Measured: 5 year
Heart failure re-hospitalization
Heart failure re-hospitalization at 1 year
Measured: 1 year
Heart failure re-hospitalization
Heart failure re-hospitalization at 2 year
Measured: 2 year
Heart failure re-hospitalization
Heart failure re-hospitalization at 3 year
Measured: 3 year
Heart failure re-hospitalization
Heart failure re-hospitalization at 4 year
Measured: 4 year
Heart failure re-hospitalization
Heart failure re-hospitalization at 5 year
Measured: 5 year
Cardiovascular mortality
Cardiovascular mortality at 1 year
Measured: 1 year
Cardiovascular mortality
Cardiovascular mortality at 2 year
Measured: 2 year
Cardiovascular mortality
Cardiovascular mortality at 3 year
Measured: 3 year
Cardiovascular mortality
Cardiovascular mortality at 4 year
Measured: 4 year
Cardiovascular mortality
Cardiovascular mortality at 5 year
Measured: 5 year
All-cause mortality or heart failure re-hospitalization
Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.
Measured: 1 year
MR severity
MR severity at 1 year
Measured: 1 year
MR severity
MR severity at 2 year
Measured: 2 year
MR severity
MR severity at 3 year
Measured: 3 year
MR severity
MR severity at 4 year
Measured: 4 year
MR severity
MR severity at 5 year
Measured: 5 year
TR severity
TR severity at 1 year
Measured: 1 year
TR severity
TR severity at 2 year
Measured: 2 year
TR severity
TR severity at 3 year
Measured: 3 year
TR severity
TR severity at 4 year
Measured: 4 year
TR severity
TR severity at 5 year
Measured: 5 year
LVEF
LVEF at 1 year
Measured: 1 year
LVEF
LVEF at 2 year
Measured: 2 year
LVEF
LVEF at 3 year
Measured: 3 year
LVEF
LVEF at 4 year
Measured: 4 year
LVEF
LVEF at 5 year
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start5 Jun 2026 (estimated)
- Primary completion5 Jun 2029 (estimated)
- Study completion5 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josep Rodes-Cabau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Investigators
- Josep Rodes Cabau, MD PhD, Principal investigator, IUCPQ-UL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623083
- Sponsor's protocol ID
- MASTER-TAVI II
- Acronym
- MASTER-TAVI II
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to patient confidentiality and privacy considerations, as well as institutional and ethical restrictions governing the use of clinical research data.
Publications
Battistolo Q, Avvedimento M, Cepas-Guillen P, Jimenez-Lozano A, Paradis JM, Beaudoin J, Belzile D, Bernier M, O Connor K, Labbe B, Salaun E, Turgeon PY, Rodes-Cabau J. Long-Term Impact of Multivalvular Heart Disease in Patients Undergoing Transcatheter Aortic Valve Replacement. Can J Cardiol. 2026 Jul;42(7):1478-1489. doi: 10.1016/j.cjca.2025.12.046. Epub 2025 Dec 31.
PubMed 41482148Toggweiler S, Boone RH, Rodes-Cabau J, Humphries KH, Lee M, Nombela-Franco L, Bagur R, Willson AB, Binder RK, Gurvitch R, Grewal J, Moss R, Munt B, Thompson CR, Freeman M, Ye J, Cheung A, Dumont E, Wood DA, Webb JG. Transcatheter aortic valve replacement: outcomes of patients with moderate or severe mitral regurgitation. J Am Coll Cardiol. 2012 Jun 5;59(23):2068-74. doi: 10.1016/j.jacc.2012.02.020. Epub 2012 Apr 4.
PubMed 22483326Hahn RT, Lawlor MK, Davidson CJ, Badhwar V, Sannino A, Spitzer E, Lurz P, Lindman BR, Topilsky Y, Baron SJ, Chadderdon S, Khalique OK, Tang GHL, Taramasso M, Grayburn PA, Badano L, Leipsic J, Lindenfeld J, Windecker S, Vemulapalli S, Redfors B, Alu MC, Cohen DJ, Rodes-Cabau J, Ailawadi G, Mack M, Ben-Yehuda O, Leon MB, Hausleiter J; TVARC Steering Committee. Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints. J Am Coll Cardiol. 2023 Oct 24;82(17):1711-1735. doi: 10.1016/j.jacc.2023.08.008. Epub 2023 Oct 4.
PubMed 37804294Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Genereux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):278-307. doi: 10.1016/j.jacc.2015.05.046.
PubMed 26184622McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.
PubMed 37622666Beghini A, Sammartino AM, Papp Z, von Haehling S, Biegus J, Ponikowski P, Adamo M, Falco L, Lombardi CM, Pagnesi M, Savarese G, Metra M, Tomasoni D. 2024 update in heart failure. ESC Heart Fail. 2025 Feb;12(1):8-42. doi: 10.1002/ehf2.14857. Epub 2024 May 28.
PubMed 38806171Donal E, Auffret V, Leurent G. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation-Reply. JAMA. 2025 May 6;333(17):1547-1548. doi: 10.1001/jama.2025.0508. No abstract available.
PubMed 40178818Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, Price MJ, Singh G, Fam N, Kar S, Schwartz JG, Mehta S, Bae R, Sekaran N, Warner T, Makar M, Zorn G, Spinner EM, Trusty PM, Benza R, Jorde U, McCarthy P, Thourani V, Tang GHL, Hahn RT, Adams DH; TRILUMINATE Pivotal Investigators. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023 May 18;388(20):1833-1842. doi: 10.1056/NEJMoa2300525. Epub 2023 Mar 4.
PubMed 36876753Kavsur R, Iliadis C, Spieker M, Brachtendorf BM, Tiyerili V, Metze C, Horn P, Baldus S, Kelm M, Nickenig G, Pfister R, Westenfeld R, Becher MU. Predictors and prognostic relevance of tricuspid alterations in patients undergoing transcatheter edge-to-edge mitral valve repair. EuroIntervention. 2021 Nov 19;17(10):827-834. doi: 10.4244/EIJ-D-20-01094.
PubMed 33646125Adamo M, Pagnesi M, Ghizzoni G, Estevez-Loureiro R, Raposeiras-Roubin S, Tomasoni D, Stolfo D, Sinagra G, Popolo Rubbio A, Bedogni F, De Marco F, Giannini C, Petronio AS, Stazzoni L, Benito-Gonzalez T, Fernandez-Vazquez F, Garrote-Coloma C, Godino C, Agricola E, Munafo A, Pascual I, Avanzas P, Leon V, Montefusco A, Boretto P, Pidello S, Monivas-Palomero V, Del Trigo M, Biagini E, Berardini A, Saia F, Nombela-Franco L, Tirado-Conte G, De Augustin A, Caneiro-Queija B, De Luca A, Branca L, Zaccone G, Lupi L, Lipsic E, Voors A, Metra M. Evolution of tricuspid regurgitation after transcatheter edge-to-edge mitral valve repair for secondary mitral regurgitation and its impact on mortality. Eur J Heart Fail. 2022 Nov;24(11):2175-2184. doi: 10.1002/ejhf.2637. Epub 2022 Aug 16.
PubMed 36482160Pavasini R, Ruggerini S, Grapsa J, Biscaglia S, Tumscitz C, Serenelli M, Boriani G, Squeri A, Campo G. Role of the tricuspid regurgitation after mitraclip and transcatheter aortic valve implantation: a systematic review and meta-analysis. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):654-659. doi: 10.1093/ehjci/jex143.
PubMed 28586413De Bonis M, Lapenna E, Sorrentino F, La Canna G, Grimaldi A, Maisano F, Torracca L, Alfieri O. Evolution of tricuspid regurgitation after mitral valve repair for functional mitral regurgitation in dilated cardiomyopathy. Eur J Cardiothorac Surg. 2008 Apr;33(4):600-6. doi: 10.1016/j.ejcts.2008.01.011. Epub 2008 Feb 12.
PubMed 18272386Shiran A, Sagie A. Tricuspid regurgitation in mitral valve disease incidence, prognostic implications, mechanism, and management. J Am Coll Cardiol. 2009 Feb 3;53(5):401-8. doi: 10.1016/j.jacc.2008.09.048.
PubMed 19179197Dreyfus GD, Martin RP, Chan KM, Dulguerov F, Alexandrescu C. Functional tricuspid regurgitation: a need to revise our understanding. J Am Coll Cardiol. 2015 Jun 2;65(21):2331-6. doi: 10.1016/j.jacc.2015.04.011.
PubMed 26022823Cremer PC, Zhang Y, Alu M, Rodriguez LL, Lindman BR, Zajarias A, Hahn RT, Lerakis S, Malaisrie SC, Douglas PS, Pibarot P, Svensson LG, Leon MB, Jaber WA. The incidence and prognostic implications of worsening right ventricular function after surgical or transcatheter aortic valve replacement: insights from PARTNER IIA. Eur Heart J. 2018 Jul 21;39(28):2659-2667. doi: 10.1093/eurheartj/ehy251.
PubMed 29741615
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT07623083
- Acronym / sponsor ID
- MASTER-TAVI II / MASTER-TAVI II
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- Aortic stenosis, Transcatheter aortic valve implantation (TAVI), Multivalvular heart disease, Mitral regurgitation, Tricuspid regurgitation, Structural heart disease, Valve disease management algorithm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Josep Rodes-CabauUniversity, hospital or other
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 5 Jun 2029 (estimated)
- Study completion
- 5 Jun 2034 (estimated)
- First posted
- 3 Jun 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.
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.
Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.
In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.
This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.
The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.
The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.
The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concomitant isolated MR - 3+ or 4 | – | –Patients with severe aortic stenosis (AS) and significant mitral regurgitation (MR) undergoing TAVI followed, if needed, by mitral intervention (M-TEER). |
| Concomitant isolated TR - 3+ to 5 | – | –Patients with severe AS and significant tricuspid regurgitation (TR) undergoing TAVI followed, if needed, by tricuspid intervention (T-TEER). |
| Concomitant MR and TR | – | –Patients with severe AS, MR, and TR undergoing staged triple-valve transcatheter therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) who also present with significant concomitant mitral regurgitation and/or tricuspid regurgitation. The study will mainly include elderly patients and patients considered at intermediate, high, or prohibitive surgical risk for conventional open-heart surgery. Eligible participants will have moderate-to-severe or severe mitral and/or tricuspid valve regurgitation identified by echocardiography before TAVI. Patients will be evaluated and treated according to a staged transcatheter treatment algorithm based on current clinical guidelines and the evolution of valve disease following TAVI.
Key inclusion criteria (3 listed)
- Age >18 years.
- Patients with severe AS undergoing transarterial TAVI.
- Concomitant significant MR and/or TR (≥3+).
Key exclusion criteria (5 listed)
- Life expectancy <1 year due to noncardiac conditions.
- Any prior mitral or tricuspid valve surgery.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Active endocarditis.
- Subjects in whom transesophageal echocardiography is contraindicated or high risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality or re-hospitalization for worsening heart failure
Time frame: Minimum of 1 year
Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure
36 secondary outcomes
All-cause mortality or re-hospitalization for worsening heart failure
Time frame: 1 Year
All-cause mortality or re-hospitalization for worsening heart failure
Time frame: 2 year
All-cause mortality or re-hospitalization for worsening heart failure
Time frame: 3 year
All-cause mortality or re-hospitalization for worsening heart failure
Time frame: 4 year
All-cause mortality or re-hospitalization for worsening heart failure
Time frame: 5 year
All-cause mortality
Time frame: 1 year
All-cause mortality
Time frame: 2 year
All-cause mortality
Time frame: 3 year
All-cause mortality
Time frame: 4 year
All-cause mortality
Time frame: 5 year
Heart failure re-hospitalization
Time frame: 1 year
Heart failure re-hospitalization
Time frame: 2 year
Heart failure re-hospitalization
Time frame: 3 year
Heart failure re-hospitalization
Time frame: 4 year
Heart failure re-hospitalization
Time frame: 5 year
Cardiovascular mortality
Time frame: 1 year
Cardiovascular mortality
Time frame: 2 year
Cardiovascular mortality
Time frame: 3 year
Cardiovascular mortality
Time frame: 4 year
Cardiovascular mortality
Time frame: 5 year
All-cause mortality or heart failure re-hospitalization
Time frame: 1 year
MR severity
Time frame: 1 year
MR severity
Time frame: 2 year
MR severity
Time frame: 3 year
MR severity
Time frame: 4 year
MR severity
Time frame: 5 year
TR severity
Time frame: 1 year
TR severity
Time frame: 2 year
TR severity
Time frame: 3 year
TR severity
Time frame: 4 year
TR severity
Time frame: 5 year
LVEF
Time frame: 1 year
LVEF
Time frame: 2 year
LVEF
Time frame: 3 year
LVEF
Time frame: 4 year
LVEF
Time frame: 5 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 3 Jun 2026.
- Background: PubMed 41482148Battistolo Q, Avvedimento M, Cepas-Guillen P, Jimenez-Lozano A, Paradis JM, Beaudoin J, Belzile D, Bernier M, O Connor K, Labbe B, Salaun E, Turgeon PY, Rodes-Cabau J. Long-Term Impact of Multivalvular Heart Disease in Patients Undergoing Transcatheter Aortic Valve Replacement. Can J Cardiol. 2026 Jul;42(7):1478-1489. doi: 10.1016/j.cjca.2025.12.046. Epub 2025 Dec 31.
- Background: PubMed 22483326Toggweiler S, Boone RH, Rodes-Cabau J, Humphries KH, Lee M, Nombela-Franco L, Bagur R, Willson AB, Binder RK, Gurvitch R, Grewal J, Moss R, Munt B, Thompson CR, Freeman M, Ye J, Cheung A, Dumont E, Wood DA, Webb JG. Transcatheter aortic valve replacement: outcomes of patients with moderate or severe mitral regurgitation. J Am Coll Cardiol. 2012 Jun 5;59(23):2068-74. doi: 10.1016/j.jacc.2012.02.020. Epub 2012 Apr 4.
- Background: PubMed 37804294Hahn RT, Lawlor MK, Davidson CJ, Badhwar V, Sannino A, Spitzer E, Lurz P, Lindman BR, Topilsky Y, Baron SJ, Chadderdon S, Khalique OK, Tang GHL, Taramasso M, Grayburn PA, Badano L, Leipsic J, Lindenfeld J, Windecker S, Vemulapalli S, Redfors B, Alu MC, Cohen DJ, Rodes-Cabau J, Ailawadi G, Mack M, Ben-Yehuda O, Leon MB, Hausleiter J; TVARC Steering Committee. Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints. J Am Coll Cardiol. 2023 Oct 24;82(17):1711-1735. doi: 10.1016/j.jacc.2023.08.008. Epub 2023 Oct 4.
- Background: PubMed 26184622Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Genereux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):278-307. doi: 10.1016/j.jacc.2015.05.046.
- Background: PubMed 37622666McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.
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- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to patient confidentiality and privacy considerations, as well as institutional and ethical restrictions governing the use of clinical research data.
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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.
Josep Rodes Cabau, MD PhD principal investigator
IUCPQ-UL
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Mitral Regurgitation, run by Josep Rodes-Cabau.
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 3 inclusion and 5 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Josep Rodes Cabau, MD PhD (14186568711 ext. 5593, josep.rodes@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality or re-hospitalization for worsening heart failure (time frame: Minimum of 1 year). 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 NCT07623083, which also lists 47 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 3 Jun 2026.