NCT03278574

Brief Summary

The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

September 6, 2017

Last Update Submit

September 10, 2017

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Freedom from significant mitral regurgitation

    Significant mitral regurgitation is defined as moderate and severe mitral regurgitation. The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation

    12 months

Secondary Outcomes (3)

  • Survival

    12 months, 24 months

  • Freedom from reoperations

    12 months, 24 months

  • Freedom from severe MR recurrence

    12 months

Study Arms (2)

Flexible band

EXPERIMENTAL

Mitral valve repair with flexible posterior annuloplasty band

Procedure: Mitral valve repairDevice: Ring annuloplasty with posterior band

Complete ring

ACTIVE COMPARATOR

Mitral valve repair with complete rigid ring

Procedure: Mitral valve repairDevice: Ring annuloplasty with complete ring

Interventions

Mitral valve repairPROCEDURE

Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation

Complete ringFlexible band
Ring annuloplasty with posterior bandDEVICE

Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band

Flexible band
Ring annuloplasty with complete ringDEVICE

Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring

Complete ring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe primary mitral regurgitation due to degenerative mitral valve disease

You may not qualify if:

  • previous open cardiac surgery,
  • indication for concomitant aortic valve replacement,
  • left ventricle impairment (ejection fraction \< 40%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bogachev-Prokophiev AV, Afanasyev AV, Zheleznev SI, Nazarov VM, Sharifulin RM, Karaskov AM. Mid-term results of mitral valve repair using flexible bands versus complete rings in patients with degenerative mitral valve disease: a prospective, randomized study. J Cardiothorac Surg. 2017 Dec 13;12(1):113. doi: 10.1186/s13019-017-0679-0.

    PMID: 29237465DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve AnnuloplastyCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 11, 2017

Study Start

September 5, 2011

Primary Completion

September 29, 2014

Study Completion

December 26, 2016

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

individual participant data is unavailable for security reason