Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry

NCT05625607 | Recruiting FDA Device

• 1 other identifier: WUM-MViV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. Significantly burdened ones are oftentimes disqualified or not referred to surgery redo. An emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. This technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (TAVI). Recent papers prove that transcatheter mitral valve replacement (TMVR) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. However, data regarding the Polish population are limited. Therefore, the aim of the study is to create a nationwide registry, collecting data from all Polish centers performing TMVR in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after TMVR as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.

Conditions

Mitral Insufficiency; Mitral Stenosis; Mitral Stenosis With Insufficiency; Heart Failure; Bioprosthesis Failure

Keywords

Transcatheter mitral valve replacement; Transcatheter mitral valve implantation; Mitral valve-in-valve; Mitral valve insufficiency; Mitral stenosis; Mitral regurgitation; Bioprosthesis failure; Left ventricle outflow tract obstruction

Outcome Measures

Primary Outcomes (5)

• Rate of all-cause mortality

  Endpoint described as n=x (y%).

  1 year

• Rate of hospitalization

  Hospitalization for valve-related symptoms or worsening congestive heart failure. Endpoint described as n=x (y%).

  1 year

• Rate of neurological events

  All stroke, transient ischemic attack (TIA). Endpoint described as n=x (y%).

  1 year

• Rate of myocardial infarction

  Endpoint described as n=x (y%).

  1 year

• Rate of valve-related dysfunction

  Mean transvalvular gradient ≥5mmHg; ≥mitral regurgitation; ≥mild paravalvular leak; left ventricle outflow tract obstruction (LVOTO)- (acute hemodynamic deterioration associated with imaging evidence of LVOTO; mean LVOT pressure gradient increasement ≥10 mmHg compared to the baseline value). Endpoint described as n=x (y%).

  1 year

Secondary Outcomes (4)

• Rate of technical success

  at 24 hours

• Rate of device success

  30 days, 6 month, 1 year

• Rate of procedural success

  30 days

• Rate of patient success

  1 year

Interventions

Transcatheter mitral valve-in-valve implantation PROCEDURE

Transcatheter transfemoral mitral valve-in-valve implantation is an alternative for surgery redo in high-surgical-risk patients with bioprosthetic valve failure. The procedure is performed via femoral vein access. By the transseptal puncture (in the postero-inferior part of the interatrial septum) and balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle. The valve is expanded in the mitral position during rapid ventricle pacing.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Polish patients with failed surgically implanted mitral bioprosthetic valves, qualified by decision of the Heart Team to TMVR. All patients meeting inclusion criteria will prospectively included in the study. Patients meeting inclusion criteria before the set-up of registry will be included retrospectively.

You may qualify if:

• Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Qualification for TMVR by decision of the local Heart Team
• Patient provided written informed consent

You may not qualify if:

• \- Disqualification from TMVR

Sponsors & Collaborators

• Medical University of Warsaw: lead
• National Institute of Cardiology, Warsaw, Poland: collaborator
• Medical University of Bialystok: collaborator
• University of Opole: collaborator
• Medical University of Gdansk: collaborator
• Medical University of Silesia: collaborator
• Medical University of Lodz: collaborator

Study Sites (7)

Medical University of Białystok

Bialystok, 15-089, Poland

RECRUITING

Medical University of Gdańsk

Gdansk, 80-210, Poland

RECRUITING

Medical University of Silesia

Katowice, 40-055, Poland

RECRUITING

Medical University of Łódź

Lodz, 90-419, Poland

RECRUITING

Medical University of Opole

Opole, 45-052, Poland

RECRUITING

Medical University of Warsaw

Warsaw, 02-091, Poland

RECRUITING

Institute of Cardiology

Warsaw, 04-628, Poland

RECRUITING

Related Publications (1)

• Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015 Aug 1;36(29):1878-91. doi: 10.1093/eurheartj/ehv333. Epub 2015 Jul 13.

  PMID: 26170468 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency; Mitral Valve Stenosis; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 23, 2022
• Study Start: October 17, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7)