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The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.
Full description
The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.
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Inclusion and exclusion criteria
Inclusion Criteria:
Exclusion Criteria
Tricuspid valve/right heart anatomy not suitable for the study device:
Moderate or greater tricuspid valve stenosis
Untreated clinically significant coronary artery disease requiring immediate revascularization
Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
Patients not already receiving dialysis with renal insufficiency (eGFR <25) per lab test ≤ 48 hours prior to scheduled implant procedure
Myocardial infarction within 30 days of scheduled implant procedure
Hemodynamic instability within 30 days of scheduled implant procedure
Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure
Severe left ventricular dysfunction with ejection fraction < 25% within 90 days of scheduled implant procedure
Patients with pulmonary artery systolic pressure > 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days
Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement
Active endocarditis or infection within 3 months of scheduled implant procedure
Cerebrovascular accident within 3 months of scheduled implant procedure
Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation
Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure
Evidence of right sided intracardiac mass, thrombus, or vegetation
Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device
Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve
Known hypersensitivity to cobalt chromium, nitinol or titanium
Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
Patient is a current intravenous drug user
Female of child-bearing potential is pregnant or lactating
Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity
Patient requires emergent/emergency treatment for tricuspid insufficiency
Patient is under guardianship
Primary purpose
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25 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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