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Tests treatment safety and results for Tricuspid Regurgitation
Official title TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System
ClinicalTrials.gov ID: NCT07334691
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- Symptomatic, NYHA Class II-IV
- Left ventricular ejection fraction (LVEF) ≥ 30%
- Subject adequately treated based upon medical standards
You likely can't join if
- people 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
See the full eligibility criteria
- 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...
- Symptomatic, NYHA Class II-IV
- Left ventricular ejection fraction (LVEF) ≥ 30%
- Subject adequately treated based upon medical standards
- people are at high risk for open heart surgery
- Subject provided written, informed consent before investigation enrollment
- Subject approved by the Subject Screening Committee Anatomical (measured by CT)
- Right femoral vein diameter \> 9mm
- Tricuspid valve diameter \< 55 mm
- RV length \> 45 mm
- people 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...
- people 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 treatment 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
- people with \>2 leads or with any lead that may interfere with Cardiovalve procedure or device
The study team makes the final eligibility decision.
Where it's taking place
- Bonn, Germany
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bonn, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.