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

July 19, 2020 updated by: Meshalkin Research Institute of Pathology of Circulation
randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • moderate or severe tricuspid regurgitation

Exclusion Criteria:

  • refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: band
Device: band implantation
Active Comparator: Rigid ring
Device: rigid ring implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 12 months
12 months
tricuspid regurgitation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
right ventricle function
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2016

Primary Completion (Actual)

September 14, 2017

Study Completion (Actual)

September 14, 2019

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BvsRR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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