TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System
ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCardiovalve Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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%
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Cardiovalve TR valve replacement System
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov