Aachen 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 Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device Used to Reduce Mitral Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572091
• Other study ID #: 06-055P
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 10, 2007
• Last updated: November 5, 2008
• Start date: February 2007
• 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 in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic heart failure

• functional MR 2+ - 4+

• LVEF 20% - 50%

Exclusion Criteria:

• MR of organic origins

• significant co-morbidities

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 Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.

Locations

Country	Name	City	State
Germany	Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen	Aachen

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 in mitral anterior posterior dimension		30 days	No
Secondary	improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max.		30 days	No

External Links

•   Sponsor Web Page (multi-lingual)