RecruitingNot Applicable

"TARGET Study": Safety and Performance of the Cardiovalve TR Replacement System

Germany100 participantsStarted 2022-12-09

Plain-language summary

The objective of this study is to evaluate the safety and performance of Cardiovalve TR system

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Functional TR ≥3+ * Symptomatic, NYHA Class II-IVa * Patient approved by the Subject Screening Committee Exclusion Criteria: * Cardiac anatomy deemed not suitable for the Cardiovalve TR system * Hemodynamic instability * Severe right ventricular failure * Refractory heart failure requiring advanced intervention

What they're measuring

Freedom from device or procedure-related adverse events

Timeframe: 30 days

Reduction in TR grade

Timeframe: 30 days

Trial details

NCT IDNCT05486832

SponsorCardiovalve Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-15

Contact for this trial

Dana Raveh Arbel

+972528591891 danar@cardiovalve.com

View on ClinicalTrials.gov More Tricuspid Regurgitation trials