Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

Not Applicable

Completed

• Conditions: Severe Tricuspid Valve Regurgitation (Disorder)
• Interventions: Procedure: Inferior Vena Caval (IVC) Occlusion maneuver

• 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

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Study Start: 2022-01-20
• Primary Completion: 2023-08-09
• Study Completion: 2023-08-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe tricuspid regurgitation due to atrial fibrillation	Inferior Vena Caval (IVC) Occlusion maneuver	Subjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver.

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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States