Tendyne European Experience Registry

Mitral Regurgitation Clinical Trial

— TENDER  

Official title:

TENDyne European expeRience Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898335
• Other study ID #: 21-0110
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2021
• Source: Klinikum der Universitaet Muenchen
• Contact: Joerg Hausleiter, MD
• Phone: 0049894400
• Email: joerg.hausleiter[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
Austria	Universitaetsklinikum Linz	Linz
Austria	Universitaetsklinikum Wien	Wien
Belgium	UZ Leuven	Leuven
France	CHU de Bordeaux	Bordeaux
France	CHU de Lille	Lille
France	CHU Rennes	Rennes
France	Clinique Pasteur	Toulouse
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitaetsklinikum Bonn	Bonn
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	UKE Hamburg	Hamburg
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Herzentrum Leipzig	Leipzig
Germany	Universitätsmedizin Mainz	Mainz
Germany	DHZ München	Münich
Germany	Universitaetsklinikum Regensburg	Regensburg
Germany	Robert-Bosch-Krankenhaus Stuttgart	Stuttgart
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Italy	ICH - Istituto Clinico Humanitas	Milan
Italy	University Hospital of Pisa	Pisa
Norway	University hospital Oslo	Oslo
Spain	Puerto de Hierro Madrid	Madrid
Spain	University hospital Madrid	Madrid
Spain	Hospital Clinico Valladolid	Valladolid
Spain	University Hospital of Vigo	Vigo
Sweden	Karolinska University Stockholm	Stockholm
Switzerland	Universitaetsspital Basel	Basel
Switzerland	Inselspital Bern	Bern
United Kingdom	Royal Brompton London	London

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Norway,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of peri-procedural myocardial infarction	Myocardial infarction during the index procedure	1 day
Secondary	Rate of conversion to open-heart surgery	Conversion to open-heart surgery during the index procedure	1 day
Secondary	Rate of cardiac tamponade	Cardiac Tamponade during the index procedure	1 day
Secondary	Rate of procedural mortality	Death during the index procedure	1 day
Secondary	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
Secondary	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
Secondary	New York Heart Association (NYHA) functional class	class I - IV	30 days, 1 year and 3 years
Secondary	6-minute walk distance (6MWD)	in m	30 days, 1 year and 3 years
Secondary	BNP/NT-proBNP level	in pg/ml	30 days, 1 year and 3 years
Secondary	Mitral regurgitation severity grade	grade 0/1+/2+/3+/4+	30 days, 1 year and 3 years
Secondary	Left and right ventricular dimensions	left/right ventricular end-diastolic/-systolic diameter (in mm)	30 days, 1 year and 3 years
Secondary	Left ventricular function	LVEF in percent	30 days, 1 year and 3 years
Secondary	Right ventricular function	TAPSE in mm	30 days, 1 year and 3 years
Secondary	Pulmonary artery pressure	in mmHg	30 days, 1 year and 3 years
Secondary	Tricuspid regurgitation severity grade	grade 1-5	30 days, 1 year and 3 years
Secondary	Transprosthetic gradient	in mmHg	30 days, 1 year and 3 years