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Clinical Trials in Spain / NCT03779490
Active, not recruiting Observational

Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)

NCT03779490 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2019-07-24
Last updated
2023-04-06

Condition(s) studied

Tricuspid RegurgitationTricuspid Insufficiency

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Repair

Transcatheter Tricuspid Valve Repair: Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR

Study summary

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
* Inclusion Criteria: * Eighteen (18) years of age or older * Moderate or greater functional Tricuspid Regurgitation (TR) * Patient is eligible to receive the Edwards Cardioband TR System per the current approved indications for use. * Exclusion Criteria: * Patients deemed anatomically unsuitable for the device by echocardiography * Patients in whom transesophageal echocardiography (TEE) is contraindicated * Previous tricuspid valve repair or replacement * Severe aortic, mitral and / or pulmonic valve stenosis * Severe aortic, mitral and / or pulmonic valve regurgitation * Renal Insufficiency requiring dialysis or severe kidney renal disease * Life expectancy of less than twelve months * Patient is pregnant or lactating

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Ulm University Ulm Bavaria
Universitätsklinik der Ruhr-Universität Bochum Bad Oeynhausen North Rhine-Westphalia
Herzzentrum der UniKlinik Köln Cologne North Rhine-Westphalia
Charité - Universitätsmedizin Campus Mitte Berlin Germany
Berlin Charité-Benjamin Franklin Berlin Germany
Universitätsklinikum Bonn Bonn Germany
Herzzentrum Universitätsklinik Dresden Dresden Germany
University Hospital Erlangen Erlangen Germany
Universitätsmedizin Göttingen, Herzzentrum Göttingen Göttingen Germany
Asklepios Klinik St. Georg Hamburg Germany
UKE Hamburg Hamburg Germany
Katholisches Marienkrankenhaus Hamburg Germany
Hospital Universitario Ramón y Cahal Madrid Spain
Universitätsspital Bern (Inselspital) Bern Switzerland

More Edwards Lifesciences trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03779490 on ClinicalTrials.gov ↗ ← All trials in Spain