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OpenTrials
Completed

NCT Number: NCT00568230

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

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

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitat Duisburg-Essen

Essen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic heart failure
  • moderate to severe mitral regurgitation
  • 20 - 50% LVEF

Exclusion criteria

  • mitral regurgitation of organic origins
  • recent interventions
  • severe comorbidities

Treatment and study plan

PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

Device

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.

Primary outcomes

  1. percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery)

    Time frame: 30 days

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Viacor

Industry

Registry information

Official study 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.

Acronym: PTOLEMY

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 5, 2007
Registry last updated
Nov 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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