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

November 5, 2008 updated by: Viacor

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, D-52057
        • Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • MR of organic origins
  • significant co-morbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
Device: PTMA Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percent of patients who remain free from device-related major adverse events: death, myocardial infarction, tamponade, emergent cardiac surgery
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 days
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viacor

Investigators

  • Principal Investigator: Rainer Hoffmann, MD, Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 6, 2008

Last Update Submitted That Met QC Criteria

November 5, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-055P

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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