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OpenTrials
Completed

NCT Number: NCT03144024

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

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

Completed

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MeshalkinRI

Novosibirsk, 630055, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderate or severe tricuspid regurgitation

Exclusion criteria

  • refusal to participate in the study

Treatment and study plan

band implantation

Device

rigid ring implantation

Device

Primary outcomes

  1. tricuspid regurgitation

    Time frame: 12 months

  2. death

    Time frame: 12 months

Secondary outcomes

  1. right ventricle function

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Acronym: BvsRR

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
May 8, 2017
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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