Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-27 @ 10:10 PM
Study NCT ID:
NCT06846502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-26
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation Using the QDOT MICRO™ Catheter
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure duration', 'timeFrame': 'Procedure', 'description': 'To study the effect of VHPSD ablation on procedure duration of PVI, compared with conventional Ablation Index-guided ablation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation; Pulmonary Vein Isolation; Very High Power Short Duration Ablation; Cardiac Magnetic Resonance'], 'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, characterized by rapid and disorganized atrial activation leading to an irregular heart rhythm. Pulmonary vein isolation (PVI) ablation is the gold standard for catheter ablation based therapy. However, recurrence of AF after PVI is common, often due to the inability to create durable ablation lesions surrounding the pulmonary veins (PV). Conventional radiofrequency (RF) ablation is typically performed with power set at 30-40 Watt for a duration of 20-30 seconds. Previous studies have shown that ablation with very higher power and shorter duration (vHPSD, 90W/4sec) may result in more continuous and more durable ablation lesions with a similar safety profile as compared to conventional ablation lesions. This new technique may consequently improve outcomes of RF ablation for AF. Moreover, HPSD ablation of AF may significantly reduce RF duration, which could lead to shorter anaesthesia, fluoroscopy and procedure duration.\n\nCardiac magnetic resonance imaging (CMR) enables studying cardiac volumes, function and atrial tissue characteristics. By applying this imaging strategy before ablation, and directly (\\<72 hours) and later (3 months) after ablation, transient (edema) and persistent (fibrosis) effects of RF ablation in the left atrial wall and surrounding tissues may be visualized and quantified.\n\nThe Q-POWER study aims to assess the effects of VHPSD RF ablation on 1) procedural characteristics, 2) acute and long-term ablation lesion formation and collateral tissue damage as assessed by CMR and 3) clinical outcomes in AF patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* AF and eligible for index PVI according to current ESC guidelines\n\nExclusion Criteria:\n\n* Unwilling or unable to give written informed consent\n* Prior left atrial ablation\n* Other left atrial arrhythmias including atrial flutters\n* Prior left atrial surgery\n* Severe mitral valve regurgitation\n* Contraindication for gadolinium-based contrast agents\n* Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia)\n* Renal insufficiency (eGFR \\< 30 ml/min)'}, 'identificationModule': {'nctId': 'NCT06846502', 'acronym': 'Q-POWER', 'briefTitle': 'High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation Using the QDOT MICRO™ Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation Using the QDOT MICRO™ Catheter - Q-POWER STUDY', 'orgStudyIdInfo': {'id': 'NL76376.029.21'}, 'secondaryIdInfos': [{'id': 'IIS-566', 'type': 'OTHER_GRANT', 'domain': 'Biosense Webster'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paroxysmal or persistent atrial fibrillation patients', 'interventionNames': ['Procedure: Pulmonary vein isolation']}], 'interventions': [{'name': 'Pulmonary vein isolation', 'type': 'PROCEDURE', 'description': 'Compared to conventional radiofrequency (RF) ablation, which is performed with a power set of 30-40 Watt for a duration of 20-30 seconds, ablation with higher power and shorter duration (vHPSD, 90W/4sec) may result in more continuous and more durable ablation lesions with a similar safety profile, while reducing procedure duration.', 'armGroupLabels': ['Paroxysmal or persistent atrial fibrillation patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Cornelis P. Allaart', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}