Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device (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

NCT00571610

05-020P

Details and patient eligibility

About

Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.

Enrollment: 5 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Functional MR 2+ - 4+ with left ventricular enlargement
• Symptomatic heart failure
• 20% - 50% LVEF

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 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