Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
NCT ID: NCT05045079
Last Updated: 2024-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2022-01-20
2023-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Moderate-severe or severe TR while in atrial fibrillation.
* Ambulatory (not wheelchair/scooter dependent).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Yogesh Reddy
Principal Investigator
Principal Investigators
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Yogesh Reddy, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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21-000537
Identifier Type: -
Identifier Source: org_study_id
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