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Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05045079
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
22.3
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Inferior Vena Caval (IVC) Occlusion maneuver
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tricuspid Regurgitation Due to Atrial Fibrillation - Impact of Rhythm Control and Early Surgery (TR-ES Study)
Actual Study Start Date :
Jan 20, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Yogesh Reddy, MBBS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Yogesh N. V. Reddy, M.B.B.S., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05045079
Other Study ID Numbers:
  • 21-000537
First Posted:
Sep 16, 2021
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Tricuspid Valve Insufficiency

Study Results

No Results Posted as of May 13, 2022