"TARGET 2.0 Study": Safety and Performance of the Cardiovalve TR Replacement System (NCT07334691) | Clinical Trial Compass
RecruitingNot Applicable
"TARGET 2.0 Study": Safety and Performance of the Cardiovalve TR Replacement System
Germany150 participantsStarted 2026-01-20
Plain-language summary
This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.
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
✓. Subject is ≥ 18 and \<85 years
✓. Severe tricuspid regurgitation (TR) ≥3+ based upon echocardiography, as assessed by independent core laboratory using a 5-grade classification (mild (1), moderate (2), severe (3), massive (4), torrential (5)). Trace and no TR is considered 0)29
✓. Symptomatic, NYHA Class II-IV
✓. Left ventricular ejection fraction (LVEF) ≥ 30%
✓. Subject adequately treated based upon medical standards
✓. Subjects are at high risk for open heart surgery
✓. Subject provided written, informed consent before investigation enrollment
✓. Subject approved by the Subject Screening Committee
Exclusion criteria
✕. Cardiac anatomy deemed not suitable for the Cardiovalve TR system as evaluated (by CT)
✕. Venous peripheral anatomy or any spinal anatomy that is unsuitable for Cardiovalve TR implant delivery (by CT)
✕. Primary tricuspid disease that may interfere with Cardiovalve implantation
✕. Severe right ventricular failure (by Echo core lab adjudication)
✕. Significant coronary artery disease requiring percutaneous or surgical intervention
What they're measuring
1
Freedom from device or procedure-related adverse events