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OpenTrials
Completed

NCT Number: NCT05045079

Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

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

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Key information

Conditions

Severe Tricuspid Valve Regurgitation (Disorder) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inferior Vena Caval (IVC) Occlusion maneuver

Procedure

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.

Primary outcomes

  1. Change in KCCQ QOL scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Tricuspid Regurgitation Due to Atrial Fibrillation - Impact of Rhythm Control and Early Surgery (TR-ES Study)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2021
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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