Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients (PTOLEMY-2)

Viacor

Status and phase: Suspended; Phase 2

Conditions: Mitral Regurgitation; Heart Failure

Treatments: Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00787293

08-010P

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Description:

Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system.

Treatment:

Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant