Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-29 @ 5:14 AM
Study NCT ID:
NCT05150366
Status:
UNKNOWN
Last Update Posted:
2021-12-09
First Post:
2021-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler (ACTIFER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2021-11-25', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "lateral e' speed", 'timeFrame': '1 day', 'description': 'measured by tissue Doppler'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tissue Doppler', 'Left Atrial Closure']}, 'descriptionModule': {'briefSummary': "The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman over 18 years-old\n* Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants\n* Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device\n* Patient in sinus rhythm\n* Subject affiliated or beneficiary of a social security scheme\n* Patient having signed the informed consent\n\nExclusion Criteria:\n\n* Patient participating in another clinical study\n* Patient in permanent ACFA\n* Patient with a mitral prosthesis (biological or mechanical),\n* Patient with a history of mitral annuloplasty\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;\n* Pregnant, breastfeeding or parturient woman;\n* Patient hospitalized without consent.'}, 'identificationModule': {'nctId': 'NCT05150366', 'acronym': 'ACTIFER', 'briefTitle': 'Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler (ACTIFER)', 'organization': {'class': 'OTHER', 'fullName': 'Ramsay Générale de Santé'}, 'officialTitle': 'Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler', 'orgStudyIdInfo': {'id': '2020-A02663-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device', 'interventionNames': ['Procedure: Trans thoracic echocardiography']}], 'interventions': [{'name': 'Trans thoracic echocardiography', 'type': 'PROCEDURE', 'description': 'trans thoracic echocardiography at the beggining and at the end of the placement of the Saint Jude Medical AMULET type prosthesis', 'armGroupLabels': ['Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-François Oudet', 'role': 'CONTACT', 'email': 'jf.oudet@ecten.eu', 'phone': '0683346567'}], 'facility': 'Hôpital Privé Le Bois', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Jean-François Oudet', 'role': 'CONTACT', 'email': 'jf.oudet@ecten.eu', 'phone': '0683346567'}, {'name': 'Marie-Hélène Barba', 'role': 'CONTACT', 'email': 'mh.barba@ecten.eu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramsay Générale de Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Clinical Trial Experts Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}