Tendyne European Experience Registry (TENDER)

TENDyne European expeRience Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: Tendyne Mitral Valve System

Detailed Description

Mitral regurgitation (MR) is a common disease and is associated with high morbidity and mortality if left untreated. Due to age and comorbidities, patients are often ineligible for surgical repair or replacement. Over the last years, transcatheter systems have been introduced as an alternative therapeutic approach. The Tendyne Mitral Valve System (Abbott Vascular, Roseville, Minnesota) is a transcatheter transapical, self-expanding valve prosthesis for mitral valve replacement. A recent study has proven safety and feasibilty of the system, leading to commercial approvement (CE mark). However, data on real world experience with the system are not available.

TENDER is a multicenter, single-device, retrospective and prospective, observational study. Objectives of the study are 1) to assess early outcomes, including safety and efficacy, in patients treated with the Tendyne Mitral Valve System for severe MR at 30 days, 2) to assess clinical outcomes in patients treated with the Tendyne Mitral Valve System for severe MR at 1 year and 3 year follow-up, and 3) to identify echocardiographic and CT-based anatomic predictors associated with outcomes.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Joerg Hausleiter, MD; Phone Number: 72360 0049894400; Email: joerg.hausleiter@med.uni-muenchen.de
• Study Contact Backup: Name: Mirjam Wild, MD; Email: mirjam.wild@insel.ch

Study Locations

• Austria
  • Linz, Austria
    • Recruiting
    • Universitaetsklinikum Linz
  • Wien, Austria
    • Recruiting
    • Universitaetsklinikum Wien
• Belgium
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
• France
  • Bordeaux, France
    • Not yet recruiting
    • CHU de Bordeaux
    • Contact: Thomas Modine
  • Lille, France
    • Recruiting
    • CHU de Lille
    • Contact: Augustin Coisine
  • Rennes, France
    • Not yet recruiting
    • CHU Rennes
    • Contact: Christophe Leclercq
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur
• Germany
  • Bad Oeynhausen, Germany
    • Recruiting
    • Herz- und Diabeteszentrum NRW
    • Contact: Tanja Rudolph
  • Berlin, Germany
    • Recruiting
    • Deutsches Herzzentrum Berlin
    • Contact: Axel Unbehaun
  • Bonn, Germany
    • Recruiting
    • Universitaetsklinikum Bonn
    • Contact: Alexander Sedaghat
  • Frankfurt, Germany
    • Recruiting
    • Universitatsklinikum Frankfurt
  • Hamburg, Germany
    • Recruiting
    • UKE Hamburg
    • Contact: Leonard Conradi
  • Koeln, Germany
    • Recruiting
    • Universitaetsklinikum Koeln
  • Leipzig, Germany
    • Not yet recruiting
    • Herzentrum Leipzig
  • Mainz, Germany
    • Recruiting
    • Universitätsmedizin Mainz
  • Münich, Germany
    • Recruiting
    • DHZ München
  • Regensburg, Germany
    • Not yet recruiting
    • Universitaetsklinikum Regensburg
    • Contact: Bernhard Unsoeld
  • Stuttgart, Germany
    • Not yet recruiting
    • Robert-Bosch-Krankenhaus Stuttgart
  • Tuebingen, Germany
    • Recruiting
    • Universitaetsklinikum Tuebingen
    • Contact: Tobias Geisler
• Italy
  • Milan, Italy
    • Recruiting
    • ICH - Istituto Clinico Humanitas
    • Contact: Andrea Fumero
  • Pisa, Italy
    • Recruiting
    • University Hospital of Pisa
• Norway
  • Oslo, Norway
    • Recruiting
    • University Hospital Oslo
• Spain
  • Madrid, Spain
    • Recruiting
    • Puerto de Hierro Madrid
    • Contact: Vanessa Monivas
  • Madrid, Spain
    • Recruiting
    • University Hospital Madrid
  • Valladolid, Spain
    • Recruiting
    • Hospital Clínico Valladolid
    • Contact: Ignacio Amat-Santos
  • Vigo, Spain
    • Recruiting
    • University Hospital of Vigo
    • Contact: Rodrigo Estevez-Loureiro
• Sweden
  • Stockholm, Sweden
    • Not yet recruiting
    • Karolinska University Stockholm
    • Contact: Andreas Rueck
• Switzerland
  • Basel, Switzerland
    • Not yet recruiting
    • Universitaetsspital Basel
  • Bern, Switzerland
    • Recruiting
    • Inselspital Bern
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Royal Brompton London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients not providing written informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tendyne; all patients treated with a Tendyne Mitral Valve System	Device: Tendyne Mitral Valve System; Tendyne Mitral Valve System for mitral valve disease in a commercial setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of peri-procedural myocardial infarction	Myocardial infarction during the index procedure	1 day
Rate of conversion to open-heart surgery	Conversion to open-heart surgery during the index procedure	1 day
Rate of cardiac tamponade	Cardiac Tamponade during the index procedure	1 day
Rate of procedural mortality	Death during the index procedure	1 day
Rate of technical success (cumulative endpoint according to MVARC)	Absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery) Device success (according to MVARC): absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient < 5 mmHg)	1 day
Rate of device success (cumulative endpoint according to MVARC)	Absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient < 5 mmHg)	30 days, 1 year and 3 years
New York Heart Association (NYHA) functional class	class I - IV	30 days, 1 year and 3 years
6-minute walk distance (6MWD)	in m	30 days, 1 year and 3 years
BNP/NT-proBNP level	in pg/ml	30 days, 1 year and 3 years
Mitral regurgitation severity grade	grade 0/1+/2+/3+/4+	30 days, 1 year and 3 years
Left and right ventricular dimensions	left/right ventricular end-diastolic/-systolic diameter (in mm)	30 days, 1 year and 3 years
Left ventricular function	LVEF in percent	30 days, 1 year and 3 years
Right ventricular function	TAPSE in mm	30 days, 1 year and 3 years
Pulmonary artery pressure	in mmHg	30 days, 1 year and 3 years
Tricuspid regurgitation severity grade	grade 1-5	30 days, 1 year and 3 years
Transprosthetic gradient	in mmHg	30 days, 1 year and 3 years

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Joerg Hausleiter, MD, LMU Klinikum Munich

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2021
• Primary Completion (ANTICIPATED): December 31, 2026
• Study Completion (ANTICIPATED): December 31, 2027

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (ACTUAL): May 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: mitral regurgitation; Tendyne; transcatheter mitral valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 21-0110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No