Severe Tricuspid Valve Regurgitation (Disorder)
Conditions
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).
Interventions
PROCEDUREInferior Vena Caval (IVC) Occlusion maneuver
During standard of care right heart catheterization (RHC), a second catheter will be inserted next to the catheter that was placed for the RHC in the jugular vein or femoral vein to assess the degree of pericardial restraint from the severe tricuspid regurgitation that may increase left sided filling pressures.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed