Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation

Official title

Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation

Overview

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.

Primary outcome measures

• All-cause mortality or re-hospitalization for worsening heart failure [Time frame: Minimum of 1 year]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• Age >18 years.
• Patients with severe AS undergoing transarterial TAVI.
• Concomitant significant MR and/or TR (≥3+).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 41482148
• Toggweiler 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 PMID 22483326
• Hahn 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 Conso PMID 37804294
• Stone 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 PMID 26184622
• McDonagh 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 Up PMID 37622666
• Beghini 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. PMID 38806171
• Donal 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. PMID 40178818
• Sorajja 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. d PMID 36876753

Identifiers

NCT: NCT07623083 · MASTER-TAVI II

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗