Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

NCT04818502 | Active Not Recruiting

• 1 other identifier: ABT-CIP-10313
• Study Type: observational
• Target: 200
• Locations: 13 countries
• Sites: 36

Brief Summary

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

Conditions

Mitral Valve Regurgitation

Keywords

Tendyne; Tendyne Mitral Valve System; Transcatheter; Mitral Regurgitation; Heart Valve disease; Mitral Valve Regurgitation; Mitral Insufficiency; Transcatheter intervention; Transcatheter Mitral Valve Implantation; Transcatheter Mitral Valve Replacement; Transapical Transcatheter Mitral Valve Implantation

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint for MR Elimination at 1 Year

  The primary endpoint MR Elimination will be assessed at one year post-procedure and is defined as original Tendyne valve remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and MR \< Grade I (mild, measured by Echocardiographic Core Lab)

  At 1 year

Secondary Outcomes (6)

• Procedure Safety (PS)

  Day 0, at exit procedure room

• Freedom from LVOT Obstruction (LVOTO) at 30 Days

  At Day 30

• Freedom from Paravalvular Leak (PVL) at 30 Days

  At Day 30

• Left Ventricle Reverse Remodeling at 1 Year

  At 1 Year

• All-Cause Mortality at 30 Days

  At Day 30

Interventions

Tendyne™ Mitral Valve System DEVICE

Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.

Also known as: Transcatheter Mitral Valve Implantation (TMVI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects of all genders from the population of patients meeting indications for a Tendyne implant as stated within the IFU. Subjects must meet all eligibility criteria and provide written informed consent.

You may qualify if:

• Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
• Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.
• Patient provides written informed consent prior to any study-specific procedure.

You may not qualify if:

• Patient is in another clinical study that may impact the follow-up or results of this study.
• Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
• Patient is under the age of 18 or age of legal consent.
• Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (36)

Kepler University Hospital

Linz, Austria

Location

UZ Gasthuisberg

Leuven, Belgium

Location

University Hospital Olomouc

Olomouc, Czechia

Location

IKEM Prague

Prague, Czechia

Location

Hospital AGEL Trinec-Podlesi

Třinec, Czechia

Location

Bordeaux University Hospital

Bordeaux, France

Location

CHRU de Lille

Lille, France

Location

Lyon University Hospital

Lyon, France

Location

Rennes University Hospital

Rennes, France

Location

Clinique Pasteur

Toulouse, France

Location

Heart and Diabetes Center NRW

Bad Oeynhausen, Germany

Location

German Heart Center Berlin

Berlin, Germany

Location

University Hospital Bonn

Bonn, Germany

Location

Universitätsclinic Cologne

Cologne, Germany

Location

University Hospital Frankfurt

Frankfurt, Germany

Location

University Heart Center Hamburg

Hamburg, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

Leipzig Heart Center

Leipzig, Germany

Location

University Medical Center Mainz

Mainz, Germany

Location

German Heart Center Munich

Munich, Germany

Location

Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern

München, Germany

Location

Robert-Bosch Krankenhaus

Stuttgart, Germany

Location

Shaare Zedek Jerusalem

Jerusalem, Israel

Location

Sheba Medical Centre

Tel Aviv, Israel

Location

Lancisi Cardiovascular Center - Politechnic University of Marcher

Ancona, Italy

Location

AOU Civili Brescia

Brescia, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

MUMC+

Maastricht, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

King Fahad Armed Forces

Jeddah, Saudi Arabia

Location

King Fahad Medical City

Riyadh, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

Location

Clinico San Carlos

Madrid, Spain

Location

University Hospital Basel, Clinic for Cardiac Surgery

Basel, Switzerland

Location

Insel Bern

Bern, Switzerland

Location

Royal Brompton Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 26, 2021
• Study Start: May 4, 2021
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2029
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12); CZ (3); AU (1); SA (3); BE (1); CH (2); IT (3); FR (5); IL (2); GB (1); ES (1); NL (1); NO (1)