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:
Viacor
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
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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
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 Heart Diseases Cardiovascular Diseases Heart Valve Diseases |
ClinicalTrials.gov processed this record on May 16, 2013