Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00787293
NCT00787293
Suspended
Phase 2

A Multi-center Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

Viacor13 sites in 5 countries30 target enrollmentOctober 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHeart FailureMitral Regurgitation

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Viacor
Enrollment
30
Locations
13
Primary Endpoint
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
Status
Suspended
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
November 2015
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Viacor

Eligibility Criteria

Inclusion Criteria

  • •Functional MR 2+ - 4+
  • •Symptomatic heart failure, NYHA Class II to IV
  • •LVEF \> 25% or \< 50% OR dilated mitral annulus \> 30mm

Exclusion Criteria

  • •MR of organic origin
  • •Severe mitral leaflet tethering
  • •History of MI or PCI within 60 days of study procedure
  • •Inability to walk a minimum of 100 meters in 6 minutes
  • •Significant left main stenosis or proximal circumflex stent
  • •Indication of non-patent CSO or discontinuous CS-GCV-AIV
  • •Bi-ventricular with leads in CS or other devices impeding device placement
  • •Severe aortic valvular disease
  • •Chronic corticosteroid use other than \< 20mg prednisone for arthritis
  • •Significant co-morbidities

Outcomes

Primary Outcomes

Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months

Time Frame: 30 days to 6 months

Secondary Outcomes

  • % of patients experiencing procedure or device-related adverse events(30 days to 6 months)
  • Technical procedural success: % of patients maintaining a reduction of mitral annulus A/P dimension, sustained MR reduction, and decrease in left ventricular dimensions to specified degrees(6 months)
  • Clinical status: % of treated patients exhibiting improvements in defined QoL parameters(6 months)

Study Sites (13)

Loading locations...

Similar Trials

Completed
Phase 1
Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral RegurgitationHeart FailureMitral Regurgitation
NCT00572091Viacor4
Completed
Phase 1
Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral RegurgitationHeart FailureMitral Regurgitation
NCT00568230Viacor12
Suspended
Phase 2
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart FailureMitral RegurgitationHeart Failure
NCT00815386Viacor20
Unknown
Not Applicable
A Multicenter, Randomized, Controlled Study to Assess Mitral vAlve reconsTrucTion for advancEd Insufficiency of Functional or iscHemic ORigiNMitral Valve Insufficiency
NCT02371512Universitätsklinikum Köln210
Recruiting
Not Applicable
Mitral Regurgitation Treatment in Advanced Heart FailureHeart FailureMitral Regurgitation
NCT05292716Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia172