Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

May 20, 2024 updated by: Yogesh Reddy, Mayo Clinic

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Severe tricuspid regurgitation due to atrial fibrillation
Subjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver.
Procedure: Inferior 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Yogesh Reddy, MBBS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

August 9, 2023

Study Completion (Actual)

August 9, 2023

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-000537

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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