Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-28 @ 9:55 AM
Study NCT ID:
NCT06392932
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2024-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esophageal Temperature During PVI Using Q-DOT Micro
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-10', 'size': 600792, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-25T19:41', 'hasProtocol': True}, {'date': '2024-04-23', 'size': 274456, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-25T19:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Interpreters of the esophageal capsule endoscopy will be blinded to study group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective open-label randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-26', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of RF ablation lesions to performed pulmonary vein isolation.', 'timeFrame': 'During ablation procedure.'}, {'measure': 'RF time during pulmonary vein isolation.', 'timeFrame': 'During ablation procedure.'}, {'measure': 'Left atrial dwell time to achieve pulmonary vein isolation.', 'timeFrame': 'During ablation procedure.'}, {'measure': 'Achievement of first pass pulmonary vein isolation.', 'timeFrame': 'During ablation procedure.'}], 'primaryOutcomes': [{'measure': 'Maximal change in esophageal temperature during posterior wall isolation.', 'timeFrame': 'During ablation procedure.'}], 'secondaryOutcomes': [{'measure': 'Presence of esophageal thermal injury seen on post-procedure capsule endoscopy.', 'timeFrame': '2-4 days after ablation procedure.'}, {'measure': 'Presence of procedural complications.', 'timeFrame': 'During and immediately following ablation procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Esophageal thermal injury'], 'conditions': ['Atrial Fibrillation Paroxysmal']}, 'descriptionModule': {'briefSummary': 'This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.', 'detailedDescription': 'This is a prospective randomized controlled trial, studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation. Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation, and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups. The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged greater than or equal to 18 years\n4. Diagnosed with paroxysmal atrial fibrillation\n5. Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned\n\nExclusion Criteria:\n\n1. Patients who have undergone prior left atrial ablation procedures.\n2. Patients where the use of the Q-DOT Micro ablation catheter in QMODE+ (i.e. temperature-controlled very-high-power short-duration ablation) is felt to be unsafe.\n3. Patients who have contraindications to capsule endoscopy, or GI conditions that may increase the risks of capsule endoscopy (e.g. esophageal strictures, inflammatory bowel disease, etc)\n4. Any records flagged "break the glass" or "research opt out."'}, 'identificationModule': {'nctId': 'NCT06392932', 'briefTitle': 'Esophageal Temperature During PVI Using Q-DOT Micro', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Esophageal Temperature Dynamics and Injury During Pulmonary Vein Isolation With Temperature Controlled Very-High-Power Short-Duration Lesions Using the Novel Q-DOT Micro Ablation Catheter', 'orgStudyIdInfo': {'id': 'STUDY00002707'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QDOT Arm', 'description': 'Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter.', 'interventionNames': ['Device: QDOT Micro ablation catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ST SF Arm', 'description': 'Conventional high-power short-duration ablation using the ThermoCool ST SF catheter.', 'interventionNames': ['Device: ST SF ablation catheter']}], 'interventions': [{'name': 'QDOT Micro ablation catheter', 'type': 'DEVICE', 'description': 'QDOT Micro ablation catheter', 'armGroupLabels': ['QDOT Arm']}, {'name': 'ST SF ablation catheter', 'type': 'DEVICE', 'description': 'ST SF ablation catheter', 'armGroupLabels': ['ST SF Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric D Braunstein, MD', 'role': 'CONTACT', 'email': 'Eric.Braunstein@cshs.org', 'phone': '310-248-6679'}], 'facility': 'Cedars-Sinai Smidt Heart Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Eric D Braunstein, MD', 'role': 'CONTACT', 'email': 'Eric.Braunstein@cshs.org', 'phone': '310-248-6679'}, {'name': 'Tansy Aguilar', 'role': 'CONTACT', 'email': 'tansy.aguilar@cshs.org'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician I', 'investigatorFullName': 'Eric Braunstein', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}