Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients (PTOLEMY-2)

February 10, 2011 updated by: Viacor

A Multi-center Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

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

  • Belgium
      • Aalst, Belgium, B-9300
        • Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst
      • Liège, Belgium, B-4000
        • Centre hospitalier universitaire de Liege
  • Czech Republic
      • Prague, Czech Republic, 1958/9
        • Institut klinické a experimentální medicíny
  • Germany
      • Aachen, Germany, D-52074
        • Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen
      • Bad Oeynhausen, Germany, D-32545
        • Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum
      • Essen, Germany, D-45122
        • Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen
      • Frankfurt, Germany, D-60389
        • Cardiovascular Center Frankfurt Sankt katharinen
      • Freiburg im Breisgau, Germany, D-79095
        • Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg
      • Karlsruhe, Germany, D-76133
        • Städtische Klinikum Karlsruhe GmbH
      • München, Germany, D-80804
        • Klinikum Schwabing Städtisches Klinikum München GmbH
  • Netherlands
      • Rotterdam, Netherlands, N-3015
        • Thoraxcentrum Erasmus Medisch Centrum
      • Utrecht, Netherlands, N-3584
        • Universitair Medisch Centrum Utrecht
  • Switzerland
      • Geneva, Switzerland, 1211
        • Hôpital Universitaire de Genève

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:

  • Functional MR 2+ - 4+
  • Symptomatic heart failure, NYHA Class II to IV
  • LVEF > 25% or < 50% OR dilated mitral annulus > 30mm

Exclusion Criteria:

  • MR of organic origin
  • Severe mitral leaflet tethering
  • History of MI or PCI within 60 days of study procedure
  • Inability to walk a minimum of 100 meters in 6 minutes
  • Significant left main stenosis or proximal circumflex stent
  • Indication of non-patent CSO or discontinuous CS-GCV-AIV
  • Bi-ventricular with leads in CS or other devices impeding device placement
  • Severe aortic valvular disease
  • Chronic corticosteroid use other than < 20mg prednisone for arthritis
  • 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. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system.
Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
Time Frame: 30 days to 6 months
30 days to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
% of patients experiencing procedure or device-related adverse events
Time Frame: 30 days to 6 months
30 days to 6 months
Technical procedural success: % of patients maintaining a reduction of mitral annulus A/P dimension, sustained MR reduction, and decrease in left ventricular dimensions to specified degrees
Time Frame: 6 months
6 months
Clinical status: % of treated patients exhibiting improvements in defined QoL parameters
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Viacor

Collaborators

Duke University
Medifacts International Corporation

Investigators

  • Principal Investigator: Stefan Sack, Md, PhD, Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH
  • Principal Investigator: Rainer Hoffmann, MD, R-WTH Universitätsklinikum Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 14, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-010P

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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