Back to resultsRhythm Control and Potential Early Surgery for Tricuspid Regurgitation
Primary Purpose
Severe Tricuspid Valve Regurgitation (Disorder)
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inferior Vena Caval (IVC) Occlusion maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Severe Tricuspid Valve Regurgitation (Disorder)
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Severe tricuspid regurgitation due to atrial fibrillation
Arm Description
Subjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05045079
Brief Title
Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
Official Title
Tricuspid Regurgitation Due to Atrial Fibrillation - Impact of Rhythm Control and Early Surgery (TR-ES Study)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Tricuspid Valve Regurgitation (Disorder)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Severe tricuspid regurgitation due to atrial fibrillation
Arm Type
Other
Arm Description
Subjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver.
Intervention Type
Procedure
Intervention Name(s)
Inferior Vena Caval (IVC) Occlusion maneuver
Intervention Description
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 Outcome Measure Information:
Title
Change in KCCQ QOL scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Irlbeck
Phone
507-266-6879
Email
Irlbeck.Colleen@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yogesh Reddy, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen M Irlbeck
Phone
507-266-6879
Email
irlbeck.colleen@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation
We'll reach out to this number within 24 hrs