Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

Mayo Clinic

Status: Completed

Conditions: Severe Tricuspid Valve Regurgitation (Disorder)

Treatments: Procedure: Inferior Vena Caval (IVC) Occlusion maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT05045079

21-000537

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Severe tricuspid regurgitation due to atrial fibrillation

Other group

Description:

Subjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver.

Treatment:

Procedure: Inferior Vena Caval (IVC) Occlusion maneuver