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

Viacor

Status and phase: Completed; Phase 2; Phase 1

Conditions: Mitral Regurgitation; Heart Failure

Treatments: Device: PTMA Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00572091

06-055P

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic heart failure
• functional MR 2+ - 4+
• LVEF 20% - 50%

Exclusion criteria

• MR of organic origins
• significant co-morbidities

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 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 Implant