Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation - Full Text View

Sponsored by:	Viacor
Information provided by:	Viacor
ClinicalTrials.gov Identifier:	NCT00568230

Purpose

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

Condition	Intervention	Phase
Heart Failure Mitral Regurgitation	Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant	Phase I

MedlinePlus related topics: Heart Failure

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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.

Further study details as provided by Viacor:

Primary Outcome Measures:

percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction of mitral annulus anterior posterior dimension [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	April 2006
Study Completion Date:	November 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patient is screened for study, and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.	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.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568230

Locations

Sponsors and Collaborators

Viacor

Investigators

Principal Investigator:

Stefan Sack, MD

Universitat Duisburg-Essen

More Information

Sponsor Web Page (multi-lingual) This link exits the ClinicalTrials.gov site

Responsible Party:	Viacor, Inc. ( Katharine M Stohlman )
Study ID Numbers:	05-023P
Study First Received:	November 30, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00568230
Health Authority:	Germany: Ethics Commission

Keywords provided by Viacor:

heart failure
mitral regurgitation

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009