Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device

Heart Failure Clinical Trial

— PTOLEMY  

Official title:

A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve Regurgitation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571610
• Other study ID #: 05-020P
• 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: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

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, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Viacor

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Dubreuil O, Basmadjian A, Ducharme A, Thibault B, Crepeau J, Lam JY, Bilodeau L. Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):1053-61. — View Citation

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 MR and reduction of mitral annulus anterior posterior dimension		30 days	No
Secondary	percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max		30 days	No

External Links

•   Sponsor Web Page (multi-lingual)