NL-OMON55204
Withdrawn
Not Applicable
A First-in-Human Study to Assess Safety and Performance of the Cardiac Implants Percutaneous Ring Annuloplasty System in the Treatment of Patients with Functional Tricuspid Regurgitation - Percutaneous Ring Annuloplasty System FIH Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- functional tricuspid regurgitation (TR)
- Sponsor
- Cardiac Implants LLC.
- Enrollment
- 10
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Moderate to Severe functional tricuspid regurgitation (FTR) as defined by
- •2\. Symptoms of right ventricular (RV) failure despite guideline directed
- •medical therapy, NYHA Class II\-IV.
- •3\. Multidisciplinary heart team (minimum of three physicians, including Imaging
- •and heart Failure cardiologists and cardiac surgery representatives) agree that
- •percutaneous tricuspid annuloplasty is a reasonable treatment option and
- •consider the subject to be a high risk for surgical annuloplasty.
- •4\. \>\=18 years old at time of enrollment.
- •5\. LVEF \>\= 30% within 45 days prior to index implant procedure.
- •6\. PASP \< 70 mmHg within 90 days prior to index implant procedure.
Exclusion Criteria
- •1\. Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV
- •inotropes).
- •2\. Severe RV dysfunction per ASE guidelines3\.
- •3\. Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
- •4\. Previous tricuspid valve repair or replacement.
- •5\. Transvalvular pacemaker or defibrillator lead is present.
- •6\. Severe left\-sided valve disease.
- •7\. Right\-sided intra\-cardiac mass, thrombus or vegetation is present.
- •8\. Inability to properly guide the index implant procedure using TEE (e.g.
- •acoustic window not adequate).
Outcomes
Primary Outcomes
Not specified
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