Clinical trial NCT04898335: Tendyne European Experience Registry
Official title: TENDyne European expeRience Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Keywords: mitral regurgitation
Tendyne
transcatheter mitral valve replacement
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients undergoing Implantation of Tendyne Mitral Valve System at the participating centres.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of procedural success
timeFrame: 30 days
Secondary outcomes:
measure: Rate of peri-procedural myocardial infarction
timeFrame: 1 day
measure: Rate of conversion to open-heart surgery
timeFrame: 1 day
measure: Rate of cardiac tamponade
timeFrame: 1 day
measure: Rate of procedural mortality
timeFrame: 1 day
measure: Rate of technical success (cumulative endpoint according to MVARC)
timeFrame: 1 day
measure: Rate of device success (cumulative endpoint according to MVARC)
timeFrame: 30 days, 1 year and 3 years
measure: New York Heart Association (NYHA) functional class
timeFrame: 30 days, 1 year and 3 years
measure: 6-minute walk distance (6MWD)
timeFrame: 30 days, 1 year and 3 years
measure: BNP/NT-proBNP level
timeFrame: 30 days, 1 year and 3 years
measure: Mitral regurgitation severity grade
timeFrame: 30 days, 1 year and 3 years
measure: Left and right ventricular dimensions
timeFrame: 30 days, 1 year and 3 years
measure: Left ventricular function
timeFrame: 30 days, 1 year and 3 years
measure: Right ventricular function
timeFrame: 30 days, 1 year and 3 years
measure: Pulmonary artery pressure
timeFrame: 30 days, 1 year and 3 years
measure: Tricuspid regurgitation severity grade
timeFrame: 30 days, 1 year and 3 years
measure: Transprosthetic gradient
timeFrame: 30 days, 1 year and 3 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Universitaetsklinikum Linz
city: Wien
country: Austria
facility: Universitaetsklinikum Wien
city: Leuven
country: Belgium
facility: UZ Leuven
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Lille
country: France
facility: CHU de Lille
city: Rennes
country: France
facility: CHU Rennes
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: UKE Hamburg
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Leipzig
country: Germany
facility: Herzentrum Leipzig
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Münich
country: Germany
facility: DHZ München
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus Stuttgart
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Milan
country: Italy
facility: ICH - Istituto Clinico Humanitas
city: Pisa
country: Italy
facility: University Hospital of Pisa
city: Oslo
country: Norway
facility: University hospital Oslo
city: Madrid
country: Spain
facility: Puerto de Hierro Madrid
city: Madrid
country: Spain
facility: University hospital Madrid
city: Valladolid
country: Spain
facility: Hospital Clinico Valladolid
city: Vigo
country: Spain
facility: University Hospital of Vigo
city: Stockholm
country: Sweden
facility: Karolinska University Stockholm
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: London
country: United Kingdom
facility: Royal Brompton London
Study officials:
affiliation: LMU Klinikum Munich
name: Joerg Hausleiter, MD
role: PRINCIPAL_INVESTIGATOR
References: