TARGET 2.0: Cardiovalve TR replacement for tricuspid regurgitation

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

This study will test a percutaneously delivered Cardiovalve tricuspid replacement via the femoral vein in adults with symptomatic severe secondary tricuspid regurgitation who are high risk for open-heart surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Cardiovalve Ltd. (Industry-sponsored)
• Locations: 1 site (Bonn)
• Trial ID: NCT07334691 on ClinicalTrials.gov

What this trial studies

TARGET 2.0 continues the original TARGET program to further demonstrate the safety and performance of the Cardiovalve TR system as a percutaneous option for severe tricuspid regurgitation. The implant is a self-expanding dual nitinol frame with three bovine pericardial leaflets and 24 anchoring points, delivered through a transfemoral venous catheter and positioned using a handle-controlled delivery system. Eligible subjects have symptomatic severe or greater secondary TR despite medical therapy and must meet CT-based anatomical criteria such as femoral vein diameter >9 mm, tricuspid diameter <55 mm, and adequate RV length. Data from this investigation will be used to support a marketing approval submission.

Who should consider this trial

Good fit: Adults aged 18–84 with symptomatic severe (≥3+) secondary tricuspid regurgitation, NYHA class II–IV, LVEF ≥30%, judged high surgical risk by a Heart Team, and meeting CT-based anatomy requirements (femoral vein >9 mm, tricuspid diameter <55 mm, RV length >45 mm) are ideal candidates.

Not a fit: Patients with cardiac or venous anatomy unsuitable for the device, left ventricular ejection fraction below 30%, or those who are good candidates for conventional surgical valve replacement are unlikely to benefit from this percutaneous approach.

Why it matters

Potential benefit: If successful, the Cardiovalve device could reduce tricuspid regurgitation and improve symptoms in patients who are poor candidates for open-heart surgery.

How similar studies have performed: Early studies of transcatheter tricuspid replacement and the initial TARGET investigation have shown promising short-term safety and reductions in TR, but large-scale and long-term outcome data are still limited.

Eligibility criteria

Inclusion Criteria:

1. Subject is ≥ 18 and \<85 years
2. 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
3. Symptomatic, NYHA Class II-IV
4. Left ventricular ejection fraction (LVEF) ≥ 30%
5. Subject adequately treated based upon medical standards
6. Subjects are at high risk for open heart surgery
7. Subject provided written, informed consent before investigation enrollment
8. Subject approved by the Subject Screening Committee

   Anatomical Inclusion Criteria (measured by CT)
9. Right femoral vein diameter \> 9mm
10. Tricuspid valve diameter \< 55 mm
11. RV length \> 45 mm

Exclusion Criteria:

Subjects will be excluded from the investigation if fulfill any of the following criteria:

1. Cardiac anatomy deemed not suitable for the Cardiovalve TR system as evaluated (by CT)
2. Venous peripheral anatomy or any spinal anatomy that is unsuitable for Cardiovalve TR implant delivery (by CT)
3. Primary tricuspid disease that may interfere with Cardiovalve implantation
4. Severe right ventricular failure (by Echo core lab adjudication)
5. Significant coronary artery disease requiring percutaneous or surgical intervention
6. Severe systolic pulmonary arterial pressure, pASP \> 2/3 systemic BP with PVR \> 5 Wood units after vasodilator challenge
7. Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year
8. Cerebrovascular event (stroke, TIA) within the past 3 months
9. Active endocarditis or history of mitral/tricuspid endocarditis within 3 months or infection requiring antibiotic within 2 weeks before index procedure
10. Subject has significant other sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, or aortic regurgitation or stenosis)
11. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count \<90k)
12. Documented evidence of significant renal dysfunction (eGFR\<30 ml/min/1.73m2) or any form of dialysis at time of screening within 30 days
13. 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)
14. Subjects unsuitable for implantation due to thrombosis of the lower venous system or presence of a vena cava filter
15. Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
16. Liver cirrhosis \> Child-Pugh Class A
17. Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol
18. Pregnant, lactating or planning pregnancy within next 12 months
19. Requirement for antibiotic treatment within the last 48 hours
20. Surgical or interventional procedure planned within 30 days prior to index procedure
21. Refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) or UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
22. Prior Tricuspid valve surgery or transcatheter tricuspid valve procedure that may interfere with the Cardiovalve device. Valve in a valve procedure is excluded.
23. Modified Rankin Scale \> 4 disability
24. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 30 days prior to index procedure
25. Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope) at the time of screening
26. Severe COPD or continuous use of home oxygen
27. Hgb \< 9 g/dL at screening
28. The subject has contraindication against a transesophageal echo (TEE) during the procedure that cannot be replaced by other imaging.
29. Currently participating in an investigational drug or another device investigation which has not reached its primary endpoint
30. Subjects with \>2 leads or with any lead that may interfere with Cardiovalve procedure or device

Where this trial is running

Bonn

• Uniklinik Bonn - — Bonn, Germany (Recruiting)

Study contacts

• Principal investigator: Georg Nickenig — Bonn Clinic
• Study coordinator: Dana Raveh Arbel

Conditions Tricuspid Regurgitation