Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
Not Applicable
Completed
- Conditions
- Severe Tricuspid Valve Regurgitation (Disorder)
- Registration Number
- NCT05045079
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
- Age ≥ 18 years.
- Moderate-severe or severe TR while in atrial fibrillation.
- Ambulatory (not wheelchair/scooter dependent).
Exclusion Criteria
- Systolic pulmonary artery pressure>70 mmHg with a fixed pulmonary vascular resistance >7 Wood units by catheterization.
- Ejection fraction <40%.
- Obstructive hypertrophic cardiomyopathy.
- Constrictive pericarditis or tamponade.
- Active myocarditis.
- Complex congenital heart disease.
- Other valve disease requiring surgical intervention.
- Terminal illness (other than HF) with expected survival of less than 1 year.
- Pregnancy or breastfeeding mothers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in KCCQ QOL scores Baseline, 6 months The KC Cardiomyopathy Questionnaire (0-100 scale) assess subject perception of heart failure limitation on their life; scale of extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, limited for other reasons or did not do the activity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Rochester🇺🇸Rochester, Minnesota, United States