Back to resultsStudy of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients (PTOLEMY-2)
Primary Purpose
Heart Failure, Mitral Regurgitation
Status
Suspended
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Mitral Regurgitation, Percutaneous, Coronary sinus
Eligibility 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
Sites / Locations
- Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst
- Centre Hospitalier Universitaire de Liège
- Institut Klinicke a Experimentalni Mediciny
- Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen
- Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum
- Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen
- CardioVascular Center Frankfurt Sankt Katharinen
- Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg
- Städtische Klinikum Karlsruhe GmbH
- Klinikum Schwabing Städtisches Klinikum München GmbH
- Thoraxcentrum Erasmus Medisch Centrum
- Universitair Medisch Centrum Utrecht
- Hôpital Universitaire de Genève
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system.
Outcomes
Primary Outcome Measures
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
Secondary Outcome Measures
% of patients experiencing procedure or device-related adverse events
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
Clinical status: % of treated patients exhibiting improvements in defined QoL parameters
Full Information
NCT ID
NCT00787293
First Posted
November 5, 2008
Last Updated
February 10, 2011
Sponsor
Viacor
Collaborators
Duke University, Medifacts International Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00787293
Brief Title
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
Acronym
PTOLEMY-2
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 Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Suspended
Why Stopped
Company ended operations January 2011
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Viacor
Collaborators
Duke University, Medifacts International Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Mitral Regurgitation
Keywords
Heart Failure, Mitral Regurgitation, Percutaneous, Coronary sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system.
Intervention Type
Device
Intervention Name(s)
PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Intervention Description
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.
Primary Outcome Measure Information:
Title
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
Time Frame
30 days to 6 months
Secondary Outcome Measure Information:
Title
% of patients experiencing procedure or device-related adverse events
Time Frame
30 days to 6 months
Title
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
Title
Clinical status: % of treated patients exhibiting improvements in defined QoL parameters
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Sack, Md, PhD
Organizational Affiliation
Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rainer Hoffmann, MD
Organizational Affiliation
R-WTH Universitätsklinikum Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst
City
Aalst
ZIP/Postal Code
B-9300
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Institut Klinicke a Experimentalni Mediciny
City
Prague
ZIP/Postal Code
1958/9
Country
Czech Republic
Facility Name
Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
D-52074
Country
Germany
Facility Name
Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum
City
Bad Oeynhausen
ZIP/Postal Code
D-32545
Country
Germany
Facility Name
Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
CardioVascular Center Frankfurt Sankt Katharinen
City
Frankfurt
ZIP/Postal Code
D-60389
Country
Germany
Facility Name
Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg
City
Freiburg im Breisgau
ZIP/Postal Code
D-79095
Country
Germany
Facility Name
Städtische Klinikum Karlsruhe GmbH
City
Karlsruhe
ZIP/Postal Code
D-76133
Country
Germany
Facility Name
Klinikum Schwabing Städtisches Klinikum München GmbH
City
München
ZIP/Postal Code
D-80804
Country
Germany
Facility Name
Thoraxcentrum Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
N-3015
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
N-3584
Country
Netherlands
Facility Name
Hôpital Universitaire de Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18592924
Citation
Fukuda S, Gillinov AM, Liddicoat JR, Saracino G, Hayase M, Cohn WE, Schneider CW, Shiota T. Maintenance of geometric alterations associated with percutaneous mitral valve repair: real-time three-dimensional echocardiographic assessment in an ovine model. J Heart Valve Dis. 2008 May;17(3):276-82.
Results Reference
background
PubMed Identifier
17400117
Citation
Daimon M, Gillinov AM, Liddicoat JR, Saracino G, Fukuda S, Koyama Y, Hayase M, Cohn WE, Ellis SG, Thomas JD, Shiota T. Dynamic change in mitral annular area and motion during percutaneous mitral annuloplasty for ischemic mitral regurgitation: preliminary animal study with real-time 3-dimensional echocardiography. J Am Soc Echocardiogr. 2007 Apr;20(4):381-8. doi: 10.1016/j.echo.2006.08.029.
Results Reference
background
PubMed Identifier
17525965
Citation
Dubreuil O, Basmadjian A, Ducharme A, Thibault B, Crepeau J, Lam JY, Bilodeau L. Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):1053-61. doi: 10.1002/ccd.21186.
Results Reference
background
PubMed Identifier
15851597
Citation
Daimon M, Shiota T, Gillinov AM, Hayase M, Ruel M, Cohn WE, Blacker SJ, Liddicoat JR. Percutaneous mitral valve repair for chronic ischemic mitral regurgitation: a real-time three-dimensional echocardiographic study in an ovine model. Circulation. 2005 May 3;111(17):2183-9. doi: 10.1161/01.CIR.0000163547.03188.AC. Epub 2005 Apr 25.
Results Reference
background
PubMed Identifier
14571496
Citation
Liddicoat JR, Mac Neill BD, Gillinov AM, Cohn WE, Chin CH, Prado AD, Pandian NG, Oesterle SN. Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation. Catheter Cardiovasc Interv. 2003 Nov;60(3):410-6. doi: 10.1002/ccd.10662.
Results Reference
background
Learn more about this trial
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
We'll reach out to this number within 24 hrs