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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00572091
Other study ID # 06-055P
Secondary ID
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


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
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