Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation (PTOLEMY)

Viacor

Status and phase: Completed; Phase 1

Conditions: Mitral Regurgitation; Heart Failure

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00568230

05-023P

Details and patient eligibility

About

Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.

Enrollment: 12 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptomatic heart failure
• moderate to severe mitral regurgitation
• 20 - 50% LVEF

Exclusion criteria

• mitral regurgitation of organic origins
• recent interventions
• severe comorbidities

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

1

Experimental group

Description:

Patient is screened for study, and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.

Treatment:

Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant