Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28 maja 2026 zaktualizowane przez: Josep Rodes-Cabau
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.
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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
300
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Melanie Côté, MSc
- Numer telefonu: 2646 4186568711
- E-mail: melanie.cote@criucpq.ulaval.ca
Kopia zapasowa kontaktu do badania
- Nazwa: Josep Rodes Cabau, MD PhD
- Numer telefonu: 5593 14186568711
- E-mail: josep.rodes@criucpq.ulaval.ca
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Ramy czasowe: 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
|
Minimum of 1 year
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Ramy czasowe: 1 Year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.
|
1 Year
|
|
All-cause mortality or re-hospitalization for worsening heart failure
Ramy czasowe: 2 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 2-year follow-up
|
2 year
|
|
All-cause mortality or re-hospitalization for worsening heart failure
Ramy czasowe: 3 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 3-year follow-up.
|
3 year
|
|
All-cause mortality or re-hospitalization for worsening heart failure
Ramy czasowe: 4 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 4-year follow-up.
|
4 year
|
|
All-cause mortality or re-hospitalization for worsening heart failure
Ramy czasowe: 5 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 5-year follow-up.
|
5 year
|
|
All-cause mortality
Ramy czasowe: 1 year
|
All-cause mortality at 1 year
|
1 year
|
|
All-cause mortality
Ramy czasowe: 2 year
|
All-cause mortality at 2 year
|
2 year
|
|
All-cause mortality
Ramy czasowe: 3 year
|
All-cause mortality at 3 year
|
3 year
|
|
All-cause mortality
Ramy czasowe: 4 year
|
All-cause mortality at 4 year
|
4 year
|
|
All-cause mortality
Ramy czasowe: 5 year
|
All-cause mortality at 5 year
|
5 year
|
|
Heart failure re-hospitalization
Ramy czasowe: 1 year
|
Heart failure re-hospitalization at 1 year
|
1 year
|
|
Heart failure re-hospitalization
Ramy czasowe: 2 year
|
Heart failure re-hospitalization at 2 year
|
2 year
|
|
Heart failure re-hospitalization
Ramy czasowe: 3 year
|
Heart failure re-hospitalization at 3 year
|
3 year
|
|
Heart failure re-hospitalization
Ramy czasowe: 4 year
|
Heart failure re-hospitalization at 4 year
|
4 year
|
|
Heart failure re-hospitalization
Ramy czasowe: 5 year
|
Heart failure re-hospitalization at 5 year
|
5 year
|
|
Cardiovascular mortality
Ramy czasowe: 1 year
|
Cardiovascular mortality at 1 year
|
1 year
|
|
Cardiovascular mortality
Ramy czasowe: 2 year
|
Cardiovascular mortality at 2 year
|
2 year
|
|
Cardiovascular mortality
Ramy czasowe: 3 year
|
Cardiovascular mortality at 3 year
|
3 year
|
|
Cardiovascular mortality
Ramy czasowe: 4 year
|
Cardiovascular mortality at 4 year
|
4 year
|
|
Cardiovascular mortality
Ramy czasowe: 5 year
|
Cardiovascular mortality at 5 year
|
5 year
|
|
All-cause mortality or heart failure re-hospitalization
Ramy czasowe: 1 year
|
Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.
|
1 year
|
|
MR severity
Ramy czasowe: 1 year
|
MR severity at 1 year
|
1 year
|
|
MR severity
Ramy czasowe: 2 year
|
MR severity at 2 year
|
2 year
|
|
MR severity
Ramy czasowe: 3 year
|
MR severity at 3 year
|
3 year
|
|
MR severity
Ramy czasowe: 4 year
|
MR severity at 4 year
|
4 year
|
|
MR severity
Ramy czasowe: 5 year
|
MR severity at 5 year
|
5 year
|
|
TR severity
Ramy czasowe: 1 year
|
TR severity at 1 year
|
1 year
|
|
TR severity
Ramy czasowe: 2 year
|
TR severity at 2 year
|
2 year
|
|
TR severity
Ramy czasowe: 3 year
|
TR severity at 3 year
|
3 year
|
|
TR severity
Ramy czasowe: 4 year
|
TR severity at 4 year
|
4 year
|
|
TR severity
Ramy czasowe: 5 year
|
TR severity at 5 year
|
5 year
|
|
LVEF
Ramy czasowe: 1 year
|
LVEF at 1 year
|
1 year
|
|
LVEF
Ramy czasowe: 2 year
|
LVEF at 2 year
|
2 year
|
|
LVEF
Ramy czasowe: 3 year
|
LVEF at 3 year
|
3 year
|
|
LVEF
Ramy czasowe: 4 year
|
LVEF at 4 year
|
4 year
|
|
LVEF
Ramy czasowe: 5 year
|
LVEF at 5 year
|
5 year
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Leon 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.
- Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
- Khan F, Okuno T, Malebranche D, Lanz J, Praz F, Stortecky S, Windecker S, Pilgrim T. Transcatheter Aortic Valve Replacement in Patients With Multivalvular Heart Disease. JACC Cardiovasc Interv. 2020 Jul 13;13(13):1503-1514. doi: 10.1016/j.jcin.2020.03.052.
- Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
- Mack 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.
- Popma 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.
- Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
- Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
- Badano LP, Muraru D, Enriquez-Sarano M. Assessment of functional tricuspid regurgitation. Eur Heart J. 2013 Jul;34(25):1875-85. doi: 10.1093/eurheartj/ehs474. Epub 2013 Jan 9.
- Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
- 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 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.
- Iung B, Delgado V, Rosenhek R, Price S, Prendergast B, Wendler O, De Bonis M, Tribouilloy C, Evangelista A, Bogachev-Prokophiev A, Apor A, Ince H, Laroche C, Popescu BA, Pierard L, Haude M, Hindricks G, Ruschitzka F, Windecker S, Bax JJ, Maggioni A, Vahanian A; EORP VHD II Investigators. Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey. Circulation. 2019 Oct;140(14):1156-1169. doi: 10.1161/CIRCULATIONAHA.119.041080. Epub 2019 Sep 12.
- Stone GW, Abraham WT, Lindenfeld J, Kar S, Grayburn PA, Lim DS, Mishell JM, Whisenant B, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Asch FM, Mack MJ; COAPT Investigators. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.
- Writing 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: 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):e25-e197. doi: 10.1016/j.jacc.2020.11.018. Epub 2020 Dec 17. No abstract available.
- Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available.
- 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. doi: 10.1056/NEJMoa2300525. Epub 2023 Mar 4.
- 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. 2025 Dec 31:S0828-282X(25)01614-9. doi: 10.1016/j.cjca.2025.12.046. Online ahead of print.
- 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. Epub 2012 Apr 4.
- 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 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.
- 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 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.
- 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.
- 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.
- Kavsur 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.
- Adamo 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.
- Pavasini 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.
- De 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.
- Shiran 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.
- Dreyfus 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.
- Cremer 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.
- Asami M, Stortecky S, Praz F, Lanz J, Raber L, Franzone A, Piccolo R, Siontis GCM, Heg D, Valgimigli M, Wenaweser P, Roost E, Windecker S, Pilgrim T. Prognostic Value of Right Ventricular Dysfunction on Clinical Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Imaging. 2019 Apr;12(4):577-587. doi: 10.1016/j.jcmg.2017.12.015. Epub 2018 Feb 14.
- Barbanti M, Binder RK, Dvir D, Tan J, Freeman M, Thompson CR, Cheung A, Wood DA, Leipsic J, Webb JG. Prevalence and impact of preoperative moderate/severe tricuspid regurgitation on patients undergoing transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2015 Mar;85(4):677-84. doi: 10.1002/ccd.25512. Epub 2014 Apr 30.
- Schwartz LA, Rozenbaum Z, Ghantous E, Kramarz J, Biner S, Ghermezi M, Shimiaie J, Finkelstein A, Banai S, Aviram G, Ingbir M, Keren G, Topilsky Y. Impact of Right Ventricular Dysfunction and Tricuspid Regurgitation on Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Soc Echocardiogr. 2017 Jan;30(1):36-46. doi: 10.1016/j.echo.2016.08.016. Epub 2016 Oct 11.
- McCarthy FH, Vemulapalli S, Li Z, Thourani V, Matsouaka RA, Desai ND, Kirtane A, Anwaruddin S, Williams ML, Giri J, Vallabhajosyula P, Li RH, Herrmann HC, Bavaria JE, Szeto WY. Association of Tricuspid Regurgitation With Transcatheter Aortic Valve Replacement Outcomes: A Report From The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Ann Thorac Surg. 2018 Apr;105(4):1121-1128. doi: 10.1016/j.athoracsur.2017.11.018. Epub 2018 Mar 2.
- Lindman BR, Maniar HS, Jaber WA, Lerakis S, Mack MJ, Suri RM, Thourani VH, Babaliaros V, Kereiakes DJ, Whisenant B, Miller DC, Tuzcu EM, Svensson LG, Xu K, Doshi D, Leon MB, Zajarias A. Effect of tricuspid regurgitation and the right heart on survival after transcatheter aortic valve replacement: insights from the Placement of Aortic Transcatheter Valves II inoperable cohort. Circ Cardiovasc Interv. 2015 Apr;8(4):10.1161/CIRCINTERVENTIONS.114.002073 e002073. doi: 10.1161/CIRCINTERVENTIONS.114.002073.
- Mascherbauer J, Kammerlander AA, Marzluf BA, Graf A, Kocher A, Bonderman D. Prognostic Impact of Tricuspid Regurgitation in Patients Undergoing Aortic Valve Surgery for Aortic Stenosis. PLoS One. 2015 Aug 20;10(8):e0136024. doi: 10.1371/journal.pone.0136024. eCollection 2015.
- Zahr F, Smith RL, Gillam LD, Chadderdon S, Makkar R, von Bardeleben RS, Ruf TF, Kipperman RM, Rassi AN, Szerlip M, Goldman S, Inglessis-Azuaje I, Yadav P, Lurz P, Davidson CJ, Mumtaz M, Gada H, Kar S, Kodali SK, Laham R, Hiesinger W, Fam NP, Kessler M, O'Neill WW, Whisenant B, Kliger C, Kapadia S, Rudolph V, Choo J, Hermiller J, Morse MA, Schofer N, Gafoor S, Latib A, Mahoney P, Kaneko T, Shah PB, Riddick JA, Muhammad KI, Boekstegers P, Price MJ, Praz F, Koulogiannis K, Marcoff L, Hausleiter J, Lim DS; CLASP IID Pivotal Trial Investigators. One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation. JACC Cardiovasc Interv. 2023 Oct 26:S1936-8798(23)01358-4. doi: 10.1016/j.jcin.2023.10.002. Online ahead of print.
- von Bardeleben RS, Mahoney P, Morse MA, Price MJ, Denti P, Maisano F, Rogers JH, Rinaldi M, De Marco F, Rollefson W, Chehab B, Williams M, Leurent G, Asch FM, Rodriguez E. 1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study. JACC Cardiovasc Interv. 2023 Nov 13;16(21):2600-2610. doi: 10.1016/j.jcin.2023.09.029. Epub 2023 Oct 24.
- Makkar RR, Chikwe J, Chakravarty T, Chen Q, O'Gara PT, Gillinov M, Mack MJ, Vekstein A, Patel D, Stebbins AL, Gelijns AC, Makar M, Bhatt DL, Kapadia S, Vemulapalli S, Leon MB. Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation. JAMA. 2023 May 23;329(20):1778-1788. doi: 10.1001/jama.2023.7089.
- Anker SD, Friede T, von Bardeleben RS, Butler J, Khan MS, Diek M, Heinrich J, Geyer M, Placzek M, Ferrari R, Abraham WT, Alfieri O, Auricchio A, Bayes-Genis A, Cleland JGF, Filippatos G, Gustafsson F, Haverkamp W, Kelm M, Kuck KH, Landmesser U, Maggioni AP, Metra M, Ninios V, Petrie MC, Rassaf T, Ruschitzka F, Schafer U, Schulze PC, Spargias K, Vahanian A, Zamorano JL, Zeiher A, Karakas M, Koehler F, Lainscak M, Oner A, Mezilis N, Theofilogiannakos EK, Ninios I, Chrissoheris M, Kourkoveli P, Papadopoulos K, Smolka G, Wojakowski W, Reczuch K, Pinto FJ, Wiewiorka L, Kalarus Z, Adamo M, Santiago-Vacas E, Ruf TF, Gross M, Tongers J, Hasenfuss G, Schillinger W, Ponikowski P; RESHAPE-HF2 Investigators. Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1799-1809. doi: 10.1056/NEJMoa2314328. Epub 2024 Aug 31.
- Connelly KA, Creati L, Lyon W, Yii M, Rosalion A, Wilson AC, Santamaria J, Jelinek VM. Early and late results of combined mitral-aortic valve surgery. Heart Lung Circ. 2007 Dec;16(6):410-5. doi: 10.1016/j.hlc.2007.03.015. Epub 2007 May 23.
- Mueller XM, Tevaearai HT, Stumpe F, Fischer AP, Hurni M, Ruchat P, von Segesser LK. Long-term results of mitral-aortic valve operations. J Thorac Cardiovasc Surg. 1998 Jun;115(6):1298-309. doi: 10.1016/s0022-5223(98)70212-0.
- Nombela-Franco L, Eltchaninoff H, Zahn R, Testa L, Leon MB, Trillo-Nouche R, D'Onofrio A, Smith CR, Webb J, Bleiziffer S, De Chiara B, Gilard M, Tamburino C, Bedogni F, Barbanti M, Salizzoni S, Garcia del Blanco B, Sabate M, Moreo A, Fernandez C, Ribeiro HB, Amat-Santos I, Urena M, Allende R, Garcia E, Macaya C, Dumont E, Pibarot P, Rodes-Cabau J. Clinical impact and evolution of mitral regurgitation following transcatheter aortic valve replacement: a meta-analysis. Heart. 2015 Sep;101(17):1395-405. doi: 10.1136/heartjnl-2014-307120. Epub 2015 Jun 9.
- Sannino A, Losi MA, Schiattarella GG, Gargiulo G, Perrino C, Stabile E, Toscano E, Giugliano G, Brevetti L, Franzone A, Cirillo P, Imbriaco M, Trimarco B, Esposito G. Meta-analysis of mortality outcomes and mitral regurgitation evolution in 4,839 patients having transcatheter aortic valve implantation for severe aortic stenosis. Am J Cardiol. 2014 Sep 15;114(6):875-82. doi: 10.1016/j.amjcard.2014.06.022. Epub 2014 Jul 2.
- Kiramijyan S, Magalhaes MA, Koifman E, Didier R, Escarcega RO, Minha S, Baker NC, Negi SI, Torguson R, Gai J, Okubagzi P, Asch FM, Gaglia MA Jr, Ben-Dor I, Satler LF, Pichard AD, Waksman R. Impact of baseline mitral regurgitation on short- and long-term outcomes following transcatheter aortic valve replacement. Am Heart J. 2016 Aug;178:19-27. doi: 10.1016/j.ahj.2016.03.020. Epub 2016 Apr 19.
- Boerlage-van Dijk K, Wiegerinck EM, Takama T, Koch KT, Vis MM, de Mol BA, Piek JJ, Bouma BJ, Baan J Jr. Mitral regurgitation prior to transcatheter aortic valve implantation influences survival but not symptoms. Int J Cardiol. 2016 Feb 1;204:95-100. doi: 10.1016/j.ijcard.2015.11.129. Epub 2015 Nov 23.
- Mavromatis K, Thourani VH, Stebbins A, Vemulapalli S, Devireddy C, Guyton RA, Matsouaka R, Ghasemzadeh N, Block PC, Leshnower BG, Stewart JP, Rumsfeld JS, Lerakis S, Babaliaros V. Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis and Mitral Regurgitation. Ann Thorac Surg. 2017 Dec;104(6):1977-1985. doi: 10.1016/j.athoracsur.2017.05.065. Epub 2017 Sep 29.
- Vollenbroich R, Stortecky S, Praz F, Lanz J, Franzone A, Zuk K, Heg D, Valgimigli M, O'Sullivan CJ, Heinisch C, Roost E, Wenaweser P, Windecker S, Pilgrim T. The impact of functional vs degenerative mitral regurgitation on clinical outcomes among patients undergoing transcatheter aortic valve implantation. Am Heart J. 2017 Feb;184:71-80. doi: 10.1016/j.ahj.2016.10.015. Epub 2016 Oct 28.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
5 czerwca 2026
Zakończenie podstawowe (Szacowany)
5 czerwca 2029
Ukończenie studiów (Szacowany)
5 czerwca 2034
Daty rejestracji na studia
Pierwszy przesłany
28 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
28 maja 2026
Pierwszy wysłany (Rzeczywisty)
3 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
3 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MASTER-TAVI II
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .