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OpenTrials
Completed

NCT Number: NCT00571610

Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device

Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.

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Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Functional MR 2+ - 4+ with left ventricular enlargement
  • Symptomatic heart failure
  • 20% - 50% LVEF

Exclusion criteria

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

Treatment and study plan

PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

Device

Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.

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 MR and reduction of mitral annulus anterior posterior dimension

    Time frame: 30 days

  2. percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Viacor

Industry

Registry information

Official study title

A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve Regurgitation.

Acronym: PTOLEMY

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 12, 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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