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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00787293
Recruitment Status : Suspended (Company ended operations January 2011)
First Posted : November 7, 2008
Last Update Posted : February 14, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.

Condition or disease Intervention/treatment Phase
Heart Failure Mitral Regurgitation Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Primary Completion Date : November 2010
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months [ Time Frame: 30 days to 6 months ]

Secondary Outcome Measures :
  1. % of patients experiencing procedure or device-related adverse events [ Time Frame: 30 days to 6 months ]
  2. 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 ]
  3. Clinical status: % of treated patients exhibiting improvements in defined QoL parameters [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787293


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

Additional Information:
Publications:
Responsible Party: Katharine M Stohlman, Viacor, Inc.
ClinicalTrials.gov Identifier: NCT00787293     History of Changes
Other Study ID Numbers: 08-010P
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: February 14, 2011
Last Verified: February 2011

Keywords provided by Viacor:
Heart Failure
Mitral Regurgitation
Percutaneous
Coronary sinus

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases