Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-01 @ 8:09 PM
Study NCT ID:
NCT02504567
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2015-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Ablation Study for trEatment of atRial Fibrillation (LASER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2015-07-15', 'studyFirstSubmitQcDate': '2015-07-20', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of large gaps in the delayed enhancement MRI (DE-MRI)', 'timeFrame': '3 months', 'description': 'The presence of MRI ablation gaps around the pulmonary veins evaluated with MRI images of the patient acquired three months after the ablation procedure. A large gap is described as a GAP that is larger or equal than 20% of the vein perimeter.'}], 'secondaryOutcomes': [{'measure': 'To determine the number of patients that present atrial fibrillation after the ablation procedure', 'timeFrame': '1 year', 'description': 'The number of patients that present a recurrence in their atrial fibrillation after the ablation procedure during the first year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Catheter Ablation', 'Radiofrequency', 'Laser', 'Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This protocol aims at assessing the efficacy of performing catheter ablation for atrial fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF) catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3 months after the procedure will be performed in both groups. MRI analysis will detect ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare the number of gaps in the laser catheter and the RF group. The secondary endpoint of the study is recurrence of AF after 12 months. The target population of the study is patients with paroxysmal or persistent AF undergoing AF ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical recurrent AF, refractary or intolerant to at least 1 antiarrhythmic drub who are scheduled to undergo ablation of pulmonary veins (PV)\n* Signed consent form.\n\nExclusion Criteria:\n\n* Being under 18 years old\n* Any contraindication for ablation procedure\n* Impossibility to acquire DE-MRI because of contraindication (e.g. severely impaired renal function) or patient unwillingness'}, 'identificationModule': {'nctId': 'NCT02504567', 'acronym': 'LASER', 'briefTitle': 'Laser Ablation Study for trEatment of atRial Fibrillation (LASER)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Laser Ablation Study for trEatment of atRial Fibrillation (LASER)', 'orgStudyIdInfo': {'id': 'Laser'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Laser ablation', 'description': 'Ablation with laser catheter', 'interventionNames': ['Device: Laser ablation']}, {'type': 'OTHER', 'label': 'RF ablation', 'description': 'Ablation with RF catheter', 'interventionNames': ['Device: RF ablation']}], 'interventions': [{'name': 'Laser ablation', 'type': 'DEVICE', 'description': 'Pulmonary vein isolation using the laser ablation catheter', 'armGroupLabels': ['Laser ablation']}, {'name': 'RF ablation', 'type': 'DEVICE', 'description': 'Pulmonary vein isolation using the RF ablation catheter', 'armGroupLabels': ['RF ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioFocus', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Phd', 'investigatorFullName': 'Josep Lluis Mont Girbau', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}