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CompletedNCT05045079Updated May 21, 2024

Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

An interventional study of Inferior Vena Caval (IVC) Occlusion maneuver in Severe Tricuspid Valve Regurgitation (Disorder), sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Severe Tricuspid Valve Regurgitation (Disorder)
03

In context

Tricuspid Valve Insufficiency

219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.

This study's enrollment of 4 is below the median of 60 across 118 interventional studies indexed under Tricuspid Valve Insufficiency.

Browse Tricuspid Valve Insufficiency studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureInferior 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.

06

What researchers measure

Primary outcomes

  1. Change in KCCQ QOL scores

    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.

    Time frame: Baseline, 6 months

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05045079
Lead sponsor
Mayo Clinic
Responsible party
Yogesh Reddy (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Sep 16, 2021
Start date
Jan 20, 2022
Primary completion
Aug 9, 2023
Completion
Aug 9, 2023
Last update
May 21, 2024

Study contacts

Yogesh Reddy, MBBS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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