RecruitingNot ApplicableNCT07334691

"TARGET 2.0 Study": Safety and Performance of the Cardiovalve TR Replacement System

"TARGET 2.0 Study": Safety and Performance of the Cardiovalve Tricuspid Valve Replacement System in the Treatment of Subjects With Tricuspid Regurgitation- Investigation

Sponsor

Cardiovalve Ltd.

Enrollment

150 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Tricuspid Regurgitation

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria11

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
Right femoral vein diameter > 9mm
Tricuspid valve diameter < 55 mm
RV length > 45 mm

Exclusion Criteria31

Subjects will be excluded from the investigation if fulfill any of the following 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
Severe systolic pulmonary arterial pressure, pASP > 2/3 systemic BP with PVR > 5 Wood units after vasodilator challenge
Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year
Cerebrovascular event (stroke, TIA) within the past 3 months
Active endocarditis or history of mitral/tricuspid endocarditis within 3 months or infection requiring antibiotic within 2 weeks before index procedure
Subject has significant other sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, or aortic regurgitation or stenosis)
Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
Documented evidence of significant renal dysfunction (eGFR<30 ml/min/1.73m2) or any form of dialysis at time of screening within 30 days
Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, contrast media, or Polyethylene Glycol (PEG)
Subjects unsuitable for implantation due to thrombosis of the lower venous system or presence of a vena cava filter
Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
Liver cirrhosis > Child-Pugh Class A
Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol
Pregnant, lactating or planning pregnancy within next 12 months
Requirement for antibiotic treatment within the last 48 hours
Surgical or interventional procedure planned within 30 days prior to index procedure
Refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) or UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
Prior Tricuspid valve surgery or transcatheter tricuspid valve procedure that may interfere with the Cardiovalve device. Valve in a valve procedure is excluded.
Modified Rankin Scale > 4 disability
Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 30 days prior to index procedure
Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope) at the time of screening
Severe COPD or continuous use of home oxygen
Hgb < 9 g/dL at screening
The subject has contraindication against a transesophageal echo (TEE) during the procedure that cannot be replaced by other imaging.
Currently participating in an investigational drug or another device investigation which has not reached its primary endpoint
Subjects with >2 leads or with any lead that may interfere with Cardiovalve procedure or device