Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery

Official title

Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study

Overview

The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.

Detailed description

Patients with symptomatic severe mitral valve disease will have a medical evaluation visit (physical examination, ECG, biology) with transthoracic ± transesophageal echocardiography in each center. If the patient is considered not eligible for surgery by the heart-team and is not included in a clinical trial, the investigator informs the patient of the existence of the registry and verifies that it does not express opposition to the use of its clinical data.

In each participating center, demographic information, clinical, laboratory, echocardiographic and treatment options will be collected and reported in an electronic case report form (e-CRF). Each center will be responsible of patient monitoring, including phone call at 6 months and a medical visit at 1 and 2 years. Transthoracic echocardiography will also be performed at 1 year and 2 years.

Primary outcome measures

• All cause death and heart failure at 24 months [Time frame: 24 months of follow-up]

Secondary outcome measures (5)

• Overall survival at 24 months [Time frame: 24 months of follow-up]
• Survival without major cardiovascular event [Time frame: 24 months of follow-up]
• Rate of unscheduled hospitalizations for heart failure [Time frame: 24 months of follow-up]
• Functional evaluation [Time frame: 24 months of follow-up]
• Early safety [Time frame: Until Hospital Discharge, up to 6 months]

Eligibility criteria

• Aged over 18 years
• Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification)
• Symptomatic (NYHA functional class II-IV) despite optimized medical therapy
• Judged not eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
• Having received information about the study and not expressing opposition to the use of their data
• Patient not included in a clinical trial

Exclusion criteria

• Asymptomatic patients
• Absence of severe mitral regurgitation or stenosis
• Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
• Pregnant or breastfeeding women
• Having not received information about the study or having expressed opposition to the use of their data

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

Cohort

Study locations

France · 3 centers

• CHU Lyon — Lyon
• CHU Nantes — Nantes
• Bichat Hospital — Paris

Publications

• Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8. PMID 16980116
• Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x. PMID 12831818
• Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disea PMID 22922698
• De Bonis M, Lapenna E, La Canna G, Ficarra E, Pagliaro M, Torracca L, Maisano F, Alfieri O. Mitral valve repair for functional mitral regurgitation in end-stage dilated cardiomyopathy: role of the "edge-to-edge" technique. Circulation. 2005 Aug 30;112(9 Suppl):I402-8. doi: 10.1161/CIRCULATIONAHA.104.525188. PMID 16159854
• Alfieri O, Maisano F, De Bonis M, Stefano PL, Torracca L, Oppizzi M, La Canna G. The double-orifice technique in mitral valve repair: a simple solution for complex problems. J Thorac Cardiovasc Surg. 2001 Oct;122(4):674-81. doi: 10.1067/mtc.2001.117277. PMID 11581597
• Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2) PMID 22222076
• Maisano F, Franzen O, Baldus S, Schafer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013 Sep 17;62(12):1052-1061. doi: 10.101 PMID 23747789
• Baldus S, Schillinger W, Franzen O, Bekeredjian R, Sievert H, Schofer J, Kuck KH, Konorza T, Mollmann H, Hehrlein C, Ouarrak T, Senges J, Meinertz T; German Transcatheter Mitral Valve Interventions (TRAMI) investigators. MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur J Heart Fail. 2012 Sep;14(9):1050-5. d PMID 22685268

Identifiers

NCT: NCT02925819 · 15.534

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗