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

NCT07334691 | Recruiting

• 1 other identifier: CP-25-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (2)

• Freedom from device or procedure-related adverse events

  Freedom from device or procedure-related adverse events

  30 days

• Reduction in TR grade

  Reduction in TR in comparison to baseline

  30 days

Secondary Outcomes (2)

• Six minute walk test

  30 days, 6 months, 12 months, annual for five years

• KCCQ

  30 days, 6 months, 12 months, annual for five years

Study Arms (1)

Cardiovalve TR valve replacement System

EXPERIMENTAL

The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.

Device: Cardiovalve TR valve replacement System

Interventions

Cardiovalve TR valve replacement System DEVICE

Cardiovalve Tricuspid Valve Replacement system

Cardiovalve TR valve replacement System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiovalve Ltd.: lead

Study Sites (2)

Uniklinik Bonn -

Bonn, 53127, Germany

RECRUITING

Bonn Clinic

Bonn, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Georg Nickenig

  Bonn Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Raveh Arbel

CONTACT

0528591891; danar@cardiovalve.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2033
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)