Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06569602
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2033-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tricuspid regurgitation grade', 'timeFrame': 'Up to 7 days, 30 days, and 1 year', 'description': 'Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)'}, {'measure': 'Number of patients with major adverse events (MAE rates)', 'timeFrame': '30 days', 'description': 'The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30 days, 1 year, and 2 years', 'description': 'Number of participants with all-cause mortality'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '30 days, 1 year, and 2 years', 'description': 'Number of participants with cardiovascular mortality'}, {'measure': 'Heart failure hospitalizations', 'timeFrame': '30 days, 1 year, and 2 years', 'description': 'Number of patients with heart failure hospitalizations'}, {'measure': 'Tricuspid valve re-intervention', 'timeFrame': '30 days, 1 year, and 2 years', 'description': 'Number of participants with tricuspid valve re-intervention'}, {'measure': 'Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores', 'timeFrame': '30 days, 1 year, and 2 years', 'description': 'KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life).'}, {'measure': 'NYHA Functional Class', 'timeFrame': '30 days, 1 year, and 2 years', 'description': 'Number of patients with improvement in NYHA class'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tricuspid Valve Regurgitation', 'Heart Valve Diseases', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.', 'detailedDescription': 'This is a prospective, single-arm, multi-center, real-world study of an approved device. Up to 500 patients will be enrolled in this study at up to 45 sites in Europe. All enrolled patients will be assessed at the following intervals: baseline, index procedure, discharge (or 7-days post-index procedure whichever occurs first), 30 days, 1 year, and annually through 5 years.\n\nStudy enrollment is expected to last approximately 2-4 years, followed by 5 years of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with at least severe tricuspid regurgitation who are candidates for transcatheter tricuspid valve replacement, selected to receive treatment with the EVOQUE system per the current Instructions for use, and meet the eligibility requirements.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.\n2. Patient agrees to attend follow-up assessments.\n3. Patients provided written informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).\n2. Any patient considered to be part of a vulnerable population.'}, 'identificationModule': {'nctId': 'NCT06569602', 'briefTitle': 'Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device', 'orgStudyIdInfo': {'id': '2024-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System', 'interventionNames': ['Device: Transcatheter Tricuspid Valve Replacement']}], 'interventions': [{'name': 'Transcatheter Tricuspid Valve Replacement', 'type': 'DEVICE', 'otherNames': ['Edwards EVOQUE Tricuspid Valve Replacement System'], 'description': 'Replacement of the tricuspid valve through a transcatheter approach', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Oeynhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Volker Rudolph, Prof. MD', 'role': 'CONTACT', 'email': 'vrudolph@hdz-nrw.de'}], 'facility': 'Herz-und Diabeteszentrum NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Bern', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Fabien Praz, Prof. MD', 'role': 'CONTACT', 'email': 'fabien.praz@insel.ch'}], 'facility': 'Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'TMTT Clinical', 'role': 'CONTACT', 'email': 'TMTT_Clinical@Edwards.com', 'phone': '+1-949-250-2500 or', 'phoneExt': '+1800-424-3278'}], 'overallOfficials': [{'name': 'Volker Rudolph, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herz-und Diabeteszentrum NRW, Bad Oeynhausen'}, {'name': 'Fabien Praz, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern, Insespital, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}