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

Heart Failure Clinical Trial

— PTOLEMY  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568230
• Other study ID #: 05-023P
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2007
• Last updated: November 5, 2008
• Start date: April 2006
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Viacor
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• symptomatic heart failure

• moderate to severe mitral regurgitation

• 20 - 50% LVEF

Exclusion Criteria:

• mitral regurgitation of organic origins

• recent interventions

• severe comorbidities

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitat Duisburg-Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Viacor

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery)		30 days	Yes
Secondary	percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction of mitral annulus anterior posterior dimension		30 days	No
Secondary	improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max		30 days	No

External Links

•   Sponsor Web Page (multi-lingual)