Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-26 @ 9:59 AM
Study NCT ID:
NCT05682066
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2022-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TVMR With the Innovalve System Trial - Pilot in Georgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of implant or delivery related serious adverse events at 30 days', 'timeFrame': '30 days', 'description': 'Absence of implant or delivery related serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Procedure', 'description': 'i. Absence of procedural mortality; and ii. Successful access, delivery, and retrieval of the device delivery system; and iii. Successful deployment and correct positioning of the first intended device; and iv. Freedom from emergency surgery or reintervention related to the device or access procedure.'}, {'measure': 'Procedural success', 'timeFrame': '30 days', 'description': 'All of the following must be present:\n\nI. Deployment of the device\n\nII. Absence of major device or procedure related serious adverse events, including:\n\n1. Death\n2. Stroke\n3. Life-threatening bleeding (MVARC scale)\n4. Major vascular complications\n5. Major cardiac structural complications\n6. Stage 2 or 3 acute kidney injury (includes new dialysis)\n7. Myocardial infarction or coronary ischemia requiring PCI or CABG\n8. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for 48 h.\n9. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention'}, {'measure': 'NYHA functional class', 'timeFrame': '30 days, 6, 1 year'}, {'measure': 'Six-minute walk test', 'timeFrame': '30 days, 6, 1 year'}, {'measure': 'Quality of life improvement (KCCQ-12) Kansas City Cardiomyopathy Questionnaire', 'timeFrame': '30 days, 6, 1 year'}, {'measure': 'Reduction in Mitral Regurgitation grade', 'timeFrame': '30 days, 6, 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Regurgitation (Degenerative or Functional)']}, 'descriptionModule': {'briefSummary': 'Study to evaluate the safety and performance of the Innovalve mitral valve replacement system', 'detailedDescription': 'The study is a multi-center, First-In-Human, prospective, single pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically significant, symptomatic mitral regurgitation\n* High risk for open-heart surgery\n* Meets anatomical criteria\n\nExclusion Criteria:\n\n* Unsuitable anatomy\n* Patient is inoperable\n* EF\\<25%'}, 'identificationModule': {'nctId': 'NCT05682066', 'acronym': 'TWIST-PILOT-GE', 'briefTitle': 'TVMR With the Innovalve System Trial - Pilot in Georgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'TVMR With the Innovalve System Trial - Pilot in Georgia', 'orgStudyIdInfo': {'id': 'INVL21-01-GE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Innovalve TMVR System', 'description': 'MV replacement with Innovalve MR system', 'interventionNames': ['Device: Innovalve MR system']}], 'interventions': [{'name': 'Innovalve MR system', 'type': 'DEVICE', 'description': 'Innovalve MR system', 'armGroupLabels': ['Innovalve TMVR System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi Heart and Vascular Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}