NCT00568230

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

An Open-Label, Single-Arm Feasibility Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty (PTMA) Device Used to Reduce Mitral Regurgitation.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Viacor · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Heart Failure
• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant	Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-04-01
• Completion: 2008-11-01
• First posted: 2007-12-05
• Last updated: 2008-11-06

Locations

1 site across 1 country: Germany