Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Stu… (NCT03779490) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
Germany150 participantsStarted 2019-07-24
Plain-language summary
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
What they're measuring
1
Procedure Success
Timeframe: Hospital discharge, 2-7 days post-procedure