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

NCT00568230 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2008-11-06

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Viacor

    lead INDUSTRY

Principal Investigators

  • Stefan Sack, MD · Universitat Duisburg-Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-04-30
Completion
2008-11-30

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00568230 on ClinicalTrials.gov