Tendyne European Experience Registry

NCT04898335 | Recruiting FDA Device

• 1 other identifier: 21-0110
• Study Type: observational
• Target: 400
• Locations: 10 countries
• Sites: 30

Brief Summary

TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

Conditions

Mitral Regurgitation

Keywords

mitral regurgitation; Tendyne; transcatheter mitral valve replacement

Outcome Measures

Primary Outcomes (1)

• Rate of procedural success

  Device success (structural and functional); absence of death, stroke, life-threatening bleeding, major vascular or cardiac structural complications, acute kidney injury, myocardial infarction, heart failure and valve-related dysfunction requiring repeat procedure

  30 days

Secondary Outcomes (16)

• Rate of peri-procedural myocardial infarction

  1 day

• Rate of conversion to open-heart surgery

  1 day

• Rate of cardiac tamponade

  1 day

• Rate of procedural mortality

  1 day

• Rate of technical success (cumulative endpoint according to MVARC)

  1 day

Study Arms (1)

Tendyne

all patients treated with a Tendyne Mitral Valve System

Device: Tendyne Mitral Valve System

Interventions

Tendyne Mitral Valve System DEVICE

Tendyne Mitral Valve System for mitral valve disease in a commercial setting

Tendyne

Eligibility Criteria

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

Study Population

All consecutive patients undergoing Implantation of Tendyne Mitral Valve System at the participating centres.

You may qualify if:

• Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting
• Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements

You may not qualify if:

• Patients not providing written informed consent

Sponsors & Collaborators

• LMU Klinikum: lead

Study Sites (30)

Universitaetsklinikum Linz

Linz, Austria

RECRUITING

Universitaetsklinikum Wien

Vienna, Austria

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

CHU de Bordeaux

Bordeaux, France

NOT YET RECRUITING

CHU de Lille

Lille, France

RECRUITING

CHU Rennes

Rennes, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, France

RECRUITING

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

RECRUITING

Deutsches Herzzentrum Berlin

Berlin, Germany

RECRUITING

Universitaetsklinikum Bonn

Bonn, Germany

RECRUITING

Universitaetsklinikum Koeln

Cologne, Germany

RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, Germany

RECRUITING

UKE Hamburg

Hamburg, Germany

RECRUITING

Herzentrum Leipzig

Leipzig, Germany

NOT YET RECRUITING

Universitätsmedizin Mainz

Mainz, Germany

RECRUITING

DHZ München

Münich, Germany

RECRUITING

Universitaetsklinikum Regensburg

Regensburg, Germany

NOT YET RECRUITING

Robert-Bosch-Krankenhaus Stuttgart

Stuttgart, Germany

NOT YET RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, Germany

RECRUITING

ICH - Istituto Clinico Humanitas

Milan, Italy

RECRUITING

University Hospital of Pisa

Pisa, Italy

RECRUITING

University hospital Oslo

Oslo, Norway

RECRUITING

Puerto de Hierro Madrid

Madrid, Spain

RECRUITING

University hospital Madrid

Madrid, Spain

RECRUITING

Hospital Clinico Valladolid

Valladolid, Spain

RECRUITING

University Hospital of Vigo

Vigo, Spain

RECRUITING

Karolinska University Stockholm

Stockholm, Sweden

NOT YET RECRUITING

Universitaetsspital Basel

Basel, Switzerland

NOT YET RECRUITING

Inselspital Bern

Bern, Switzerland

RECRUITING

Royal Brompton London

London, United Kingdom

RECRUITING

Related Publications (1)

• Hell MM, Wild MG, Baldus S, Rudolph T, Treede H, Petronio AS, Modine T, Andreas M, Coisne A, Duncan A, Franco LN, Praz F, Ruge H, Conradi L, Zierer A, Anselmi A, Dumonteil N, Nickenig G, Pinon M, Barth S, Adamo M, Dubois C, Torracca L, Maisano F, Lurz P, von Bardeleben RS, Hausleiter J; TENDER Investigators. Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry. JACC Cardiovasc Interv. 2024 Mar 11;17(5):648-661. doi: 10.1016/j.jcin.2023.12.027. Epub 2024 Feb 21.

  PMID: 38385922 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Joerg Hausleiter, MD

  LMU Klinikum Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joerg Hausleiter, MD

CONTACT

0049894400; joerg.hausleiter@med.uni-muenchen.de

Mirjam Wild, MD

CONTACT

mirjam.wild@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Jörg Hausleiter

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 24, 2021
• Study Start: April 15, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12); IT (2); SE (1); CH (2); ES (4); GB (1); AU (2); NO (1); FR (4); BE (1)