Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 12:40 PM
Study NCT ID:
NCT06647251
Status:
RECRUITING
Last Update Posted:
2024-10-17
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to one of the following arms: Q-MODE, Q-MODE+, hybride Q-MODE/Q-MODE+.\n\nThe number of patients in each arm is the same.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of primary adverse events related to the ablation procedure', 'timeFrame': '7 days after ablation', 'description': 'Incidence of primary adverse events within 7 days after ablation in the 3 arms'}, {'measure': 'Acute procedural success', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Acute procedural success is defined as electrical isolation of all pulmonary veins'}], 'secondaryOutcomes': [{'measure': 'Incidence of serious adverse event', 'timeFrame': 'within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure', 'description': 'Incidence of serious adverse events'}, {'measure': 'Rate of additional lesions', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Rate of additional lesions between all targeted veins and per subject'}, {'measure': 'Location of additional lesions', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Anatomical location of additional lesions'}, {'measure': 'Use of another catheter', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Use of another catheter than QDOT in all targeted veins'}, {'measure': 'Time spent in operating room', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Time spent in operating room'}, {'measure': 'Skin-to-skin time', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Skin-to-skin time'}, {'measure': 'Glove-to-glove time', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Glove-to-glove time = total procedure time'}, {'measure': 'Mapping time', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Mapping time'}, {'measure': 'Total ablation time', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Total ablation time'}, {'measure': 'Left vein ablation time', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Left vein ablation time'}, {'measure': 'Right vein ablation time', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Right vein ablation time'}, {'measure': 'Number of radiofrequency applications', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Number of radiofrequency applications'}, {'measure': 'Number of vHPSD radiofrequency applications', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Number of vHPSD (very High Power Short Duration) radiofrequency applications'}, {'measure': 'Number of HPSD radiofrequency applications', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Number of HPSD (High Power Short Duration) radiofrequency applications'}, {'measure': 'Temperature', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Temperature'}, {'measure': 'Power', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Power'}, {'measure': 'Contact force', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Contact force'}, {'measure': 'Impedance', 'timeFrame': 'At the end of the ablation procedure', 'description': 'Impedance'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Pulmonary vein isolation is the main treatment of paroxysmal and persistent atrial fibrillation.\n\nThe aim of our study is to prospectively compare the efficacy and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions', 'detailedDescription': 'Pulmonary vein isolation (PVI) is the main treatment of paroxysmal and persistant atrial fibrillation.\n\nPVI is achieved by point-by-point radiofrequency ablation that creates flexible lesion set within targeted area.\n\nPVI using standard ablation catheter with limited power (50W) have been described in case series with favorable efficacy and safety.\n\nQDOTMicro™ is a radiofrequency ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution.\n\nQDOT Micro™ provides several options regarding radiofrequency administration :\n\n* Q-MODE : provides high power short duration (HPSD) unitl 50W radiofrequency,\n* Q-MODE+ : provides very high power very short duration (vHSPD) until 90W radiofrequency,\n* Hybrid Q-MODE/Q-MODE+ : is a combination of two methods. In our experience, stability is a prerequisite for PVI with QDOT Micro™.\n\nSmall series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).\n\nRecently, preliminary animal data argue in favor or reducing the interpoint distance with QDOT™.\n\nTo date, there is no study comparing the 3 options of radiofrequency delivery. The aim of our study is to prospectively compare the efficacity and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions.\n\nThe same device is used in all three randomisation groups. The difference between the intervention is the intensity of the radiofrequency applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 or over\n* First atrial fibrillation ablation\n* Paroxysmal atrial fibillation defined as atrial fibrillation lasting less than 48 hours\n* Early atrial fibrillation defined as atrial fibrillation lastiing between 7 days and 3 months\n* At least one episode of atrial fibrillation in the year preceding study entry\n* Patient affiliated to a health insurance\n\nExclusion Criteria:\n\n* History of atrial fibrillation ablation (surgery or catheter)\n* Documented left atrial thrombus\n* Left atrial (LA) diameter \\> 60mm / LA area \\> 35cm2 / Left atrial volulme index (LAVI) \\> 45ml/m2\n* N/STEMI replacement or angioplasty or valve within 3 months prior to registration\n* Any contraindication mentioned in the instructions for use of the QDOT MICRO™ bidirectional navigation catheter\n* Patient unable to understand study information\n* Patient deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT06647251', 'acronym': 'QDOT', 'briefTitle': 'Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study', 'orgStudyIdInfo': {'id': 'RYTHMO-03-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Q-MODE', 'description': 'Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W.', 'interventionNames': ['Procedure: Q-MODE : radiofrequency ablation up to 50W']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Q-MODE+', 'description': 'Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W.', 'interventionNames': ['Procedure: Q-MODE+ : radiofrequency up to 90W']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hybride Q-MODE/Q-MODE+', 'description': 'A combination of the two ablation methods.', 'interventionNames': ['Procedure: Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part']}], 'interventions': [{'name': 'Q-MODE : radiofrequency ablation up to 50W', 'type': 'PROCEDURE', 'description': 'The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care.\n\nFor patient randomized in this arm, the device is set to Q-MODE option: the intensity of radiofrequency to isolate the pulmonary vein is limited to 50W.', 'armGroupLabels': ['Q-MODE']}, {'name': 'Q-MODE+ : radiofrequency up to 90W', 'type': 'PROCEDURE', 'description': 'The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care.\n\nFor patient randomized in this arm, the device is set to Q-MODE+ option: the intensity of radiofrequency to isolate the pulmonary vein is limited to 90W.', 'armGroupLabels': ['Q-MODE+']}, {'name': 'Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part', 'type': 'PROCEDURE', 'description': 'The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care.\n\nFor patient randomized in this arm, the device is set to "Q-MODE/Q-MODE+" option: the intensity of radiofrequency delivered to isolate the pulmonary vein is limited to 50W in the anterior part and to 90W in the posterior part.', 'armGroupLabels': ['Hybride Q-MODE/Q-MODE+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frederic SEBAG', 'role': 'CONTACT', 'email': 'frederic.sebag@imm.fr', 'phone': '+33156616263'}], 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Naly ANDRIAMBAO', 'role': 'CONTACT', 'email': 'naly.andriambao@imm.fr', 'phone': '+33156616439'}], 'overallOfficials': [{'name': 'Frédéric SEBAG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Mutualiste Montsouris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}