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

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ClinicalTrials.gov Identifier: NCT03144024
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: band implantation Device: rigid ring implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
Actual Study Start Date : September 14, 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: band Device: band implantation
Active Comparator: Rigid ring Device: rigid ring implantation



Primary Outcome Measures :
  1. tricuspid regurgitation [ Time Frame: 12 months ]
  2. death [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. right ventricle function [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate or severe tricuspid regurgitation

Exclusion Criteria:

  • refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144024


Contacts
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Contact: Mikhail Ovcharov +79132300835 mihail.ovcharoff@gmail.com
Contact: Alexander Bogachev-Prokophiev +79137539546 bogachev.prokophiev@gmail.com

Locations
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Russian Federation
MeshalkinRI Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Mikhail Ovcharov    +79132300835    mihail.ovcharoff@gmail.com   
Principal Investigator: Mikhail Ovcharov         
Sub-Investigator: Alexander Bogachev-Prokophiev         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT03144024     History of Changes
Other Study ID Numbers: BvsRR
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: September 2016

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Tricuspid Regurgitation
Insufficiency, Tricuspid Valve
Valvular Annuloplasty
Cardiac Valve Annulus Repair

Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases