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

Tricuspid Regurgitation Clinical Trial

— TriBAND  

Official title:

Transcatheter Repair of Tricuspid Regurgitation With Cardioband TR System Post-Market Clinical Follow-Up Study (TriBAND): A European Prospective, Multicenter Post-market Clinical Follow-up Study to Assess Transcatheter Tricuspid Valve Repair With Edwards Cardioband TR System in Patients With Symptomatic Chronic Functional Tricuspid Regurgitation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03779490
• Other study ID #: 2017-21
• Status: Active, not recruiting
• Start date: July 24, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market Clinical Follow up Study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Tricuspid Insufficiency
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Success	Reduction in severity of Tricuspid Regurgitation at discharge.	Hospital discharge, 2-7 days post-procedure
Secondary	Major Adverse Event Rate	Rates of major adverse	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Procedure Success	Reduction in severity of Tricuspid Regurgitation (TR) severity	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Change in Quality of Life - KCCQ	Improvement in Quality of Life as assessed by KCCQ.	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Change in Quality of Life - EQ-5D-5L	Improvement in Quality of Life as assessed by EQ-5D-5L	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years