Ignite Creation Date:
2025-12-17 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 2:52 AM
Study NCT ID:
NCT00787293
Status:
SUSPENDED
Last Update Posted:
2011-02-14
First Post:
2008-11-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016254', 'term': 'Mutagenesis, Insertional'}], 'ancestors': [{'id': 'D015202', 'term': 'Protein Engineering'}, {'id': 'D005818', 'term': 'Genetic Engineering'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009154', 'term': 'Mutation'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D016296', 'term': 'Mutagenesis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'Company ended operations January 2011', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-10', 'studyFirstSubmitDate': '2008-11-05', 'studyFirstSubmitQcDate': '2008-11-05', 'lastUpdatePostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months', 'timeFrame': '30 days to 6 months'}], 'secondaryOutcomes': [{'measure': '% of patients experiencing procedure or device-related adverse events', 'timeFrame': '30 days to 6 months'}, {'measure': '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', 'timeFrame': '6 months'}, {'measure': 'Clinical status: % of treated patients exhibiting improvements in defined QoL parameters', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Mitral Regurgitation', 'Percutaneous', 'Coronary sinus'], 'conditions': ['Heart Failure', 'Mitral Regurgitation']}, 'referencesModule': {'references': [{'pmid': '18592924', 'type': 'BACKGROUND', '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.'}, {'pmid': '17400117', 'type': 'BACKGROUND', '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.'}, {'pmid': '17525965', 'type': 'BACKGROUND', '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.'}, {'pmid': '15851597', 'type': 'BACKGROUND', '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.'}, {'pmid': '14571496', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Functional MR 2+ - 4+\n* Symptomatic heart failure, NYHA Class II to IV\n* LVEF \\> 25% or \\< 50% OR dilated mitral annulus \\> 30mm\n\nExclusion Criteria:\n\n* MR of organic origin\n* Severe mitral leaflet tethering\n* History of MI or PCI within 60 days of study procedure\n* Inability to walk a minimum of 100 meters in 6 minutes\n* Significant left main stenosis or proximal circumflex stent\n* Indication of non-patent CSO or discontinuous CS-GCV-AIV\n* Bi-ventricular with leads in CS or other devices impeding device placement\n* Severe aortic valvular disease\n* Chronic corticosteroid use other than \\< 20mg prednisone for arthritis\n* Significant co-morbidities'}, 'identificationModule': {'nctId': 'NCT00787293', 'acronym': 'PTOLEMY-2', 'briefTitle': 'Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viacor'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '08-010P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system.', 'interventionNames': ['Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant']}], 'interventions': [{'name': 'PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant', 'type': 'DEVICE', 'description': 'Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': 'B-4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '1958/9', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institut Klinicke a Experimentalni Mediciny', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': 'D-52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': 'D-32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': 'D-45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-60389', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'CardioVascular Center Frankfurt Sankt Katharinen', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-79095', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': 'D-76133', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Städtische Klinikum Karlsruhe GmbH', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': 'D-80804', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum Schwabing Städtisches Klinikum München GmbH', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'N-3015', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Thoraxcentrum Erasmus Medisch Centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': 'N-3584', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpital Universitaire de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Stefan Sack, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH'}, {'name': 'Rainer Hoffmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'R-WTH Universitätsklinikum Aachen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viacor', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Medifacts International Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Katharine M Stohlman', 'oldOrganization': 'Viacor, Inc.'}}}}