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NCT03144024 Clinical Trial

Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency

Tricuspid Regurgitation Clinical Trial

— BvsRR  

Official title:
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03144024
Other study ID # BvsRR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2016
Est. completion date September 14, 2019

Study information
Verified date September 2016
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.

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.

Recruitment information / eligibility
Status Completed
Enrollment 308
Est. completion date September 14, 2019
Est. primary completion date September 14, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- moderate or severe tricuspid regurgitation

Exclusion Criteria:

- refusal to participate in the study

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• band implantation

• rigid ring implantation

Locations
Country Name City State
Russian Federation MeshalkinRI Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary tricuspid regurgitation 12 months
Primary death 12 months
Secondary right ventricle function 12 months
See also
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Not yet recruiting NCT05173233 - Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System N/A