Back to resultsComparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency (BvsRR)
Primary Purpose
Tricuspid Regurgitation
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
band implantation
rigid ring implantation
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring Tricuspid Regurgitation, Insufficiency, Tricuspid Valve, Valvular Annuloplasty, Cardiac Valve Annulus Repair
Eligibility Criteria
Inclusion Criteria:
- moderate or severe tricuspid regurgitation
Exclusion Criteria:
- refusal to participate in the study
Sites / Locations
- MeshalkinRI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
band
Rigid ring
Arm Description
Outcomes
Primary Outcome Measures
tricuspid regurgitation
death
Secondary Outcome Measures
right ventricle function
Full Information
NCT ID
NCT03144024
First Posted
May 4, 2017
Last Updated
July 19, 2020
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT03144024
Brief Title
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
Acronym
BvsRR
Official Title
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
September 14, 2017 (Actual)
Study Completion Date
September 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.
Detailed Description
study include 308 patients. Patient will be randomized and 154 patient will receive band for treatment tricuspid regurgitation, rest patient will receive rigid ring. Follow up will be 1 year. Primary outcome - freedom of moderate or severe regurgitation. Secondary outcome - RV function, quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
Keywords
Tricuspid Regurgitation, Insufficiency, Tricuspid Valve, Valvular Annuloplasty, Cardiac Valve Annulus Repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
band
Arm Type
Experimental
Arm Title
Rigid ring
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
band implantation
Intervention Type
Device
Intervention Name(s)
rigid ring implantation
Primary Outcome Measure Information:
Title
tricuspid regurgitation
Time Frame
12 months
Title
death
Time Frame
12 months
Secondary Outcome Measure Information:
Title
right ventricle function
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
moderate or severe tricuspid regurgitation
Exclusion Criteria:
refusal to participate in the study
Facility Information:
Facility Name
MeshalkinRI
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
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