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

This study has suspended participant recruitment.
(Company ended operations January 2011)
Sponsor:
Collaborators:
Duke University
Medifacts International Corporation
Information provided by:
Viacor
ClinicalTrials.gov Identifier:
NCT00787293
First received: November 5, 2008
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Viacor:

Primary Outcome Measures:
  • Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months [ Time Frame: 30 days to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • % of patients experiencing procedure or device-related adverse events [ Time Frame: 30 days to 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical status: % of treated patients exhibiting improvements in defined QoL parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: November 2015
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 5, 2008
Last Updated: February 10, 2011
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 20, 2014