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Completed

NCT Number: NCT00572091

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

Improvement in 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

Aachen, D-52057, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic heart failure
  • functional MR 2+ - 4+
  • LVEF 20% - 50%

Exclusion criteria

  • MR of organic origins
  • significant co-morbidities

Treatment and study plan

PTMA Implant

Device

Percutaneous assessment from right or left subclavian vein, with 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 mitral regurgitation and reduction in mitral anterior posterior dimension

    Time frame: 30 days

  2. 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.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Viacor

Industry

Registry information

Official study title

An Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device Used to Reduce Mitral Regurgitation

Acronym: PTOLEMY

Important dates

Study start
2007
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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