Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

Mayo Clinic4 enrolled

Overview

The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Tricuspid Valve Regurgitation (Disorder)

Interventions

Inferior Vena Caval (IVC) Occlusion maneuverPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in KCCQ QOL scores

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.

Time frame: Baseline, 6 months

Data from ClinicalTrials.gov

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