Actively Recruiting
TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System
Led by Cardiovalve Ltd. · Updated on 2026-05-11
150
Participants Needed
1
Research Sites
397 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and less than 85 years
- Severe tricuspid regurgitation (grade 3 or higher) based on echocardiography
- Symptoms classified as NYHA Class II to IV
- Left ventricular ejection fraction of 30% or greater
- Receiving appropriate medical treatment
- High risk for open heart surgery
- Provided written informed consent before joining
- Approved by the Subject Screening Committee
- Right femoral vein diameter greater than 9 mm (measured by CT)
- Tricuspid valve diameter less than 55 mm (measured by CT)
- Right ventricular length greater than 45 mm (measured by CT)
You will not qualify if you...
- Cardiac or venous anatomy unsuitable for Cardiovalve system (evaluated by CT)
- Primary tricuspid disease interfering with implantation
- Severe right ventricular failure
- Significant coronary artery disease needing intervention
- Severe pulmonary arterial pressure or high pulmonary vascular resistance
- Life-threatening non-cardiac disease limiting life expectancy to under one year
- Stroke or transient ischemic attack within past 3 months
- Active or recent endocarditis or recent infection requiring antibiotics
- Significant other valvular heart diseases requiring treatment
- Primary coagulopathy or platelet disorder including low platelet count
- Significant kidney dysfunction or dialysis within past 30 days
- Allergies or contraindications to device materials or medications used
- Thrombosis in lower veins or vena cava filter presence
- Heart attack within past 30 days
- Liver cirrhosis beyond Child-Pugh Class A
- Psychiatric or behavioral issues likely to affect compliance
- Pregnant, breastfeeding, or planning pregnancy within 12 months
- Antibiotic treatment within last 48 hours
- Planned surgery or intervention within 30 days before procedure
- Advanced heart failure needing assist devices or transplant
- Prior tricuspid valve surgery or procedure that may interfere
- Major disability (Modified Rankin Scale over 4)
- Recent device implantation or revision within 30 days
- Unstable heart failure at screening
- Severe COPD or continuous home oxygen use
- Hemoglobin below 9 g/dL at screening
- Contraindication to transesophageal echo not replaceable by other imaging
- Participation in other investigational drug or device trials not completed
- More than 2 leads or leads interfering with Cardiovalve procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Uniklinik Bonn -
Bonn, Germany, 53127
Actively Recruiting
Research Team
D
Dana Raveh Arbel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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