Nctid:
NCT06617442
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000004939", "term"=>"Esophageal Perforation"}, {"id"=>"D000001281", "term"=>"Atrial Fibrillation"}], "ancestors"=>[{"id"=>"D000001145", "term"=>"Arrhythmias, Cardiac"}, {"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000004935", "term"=>"Esophageal Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M4586", "name"=>"Atrial Fibrillation", "asFound"=>"Atrial Fibrillation (AF)", "relevance"=>"HIGH"}, {"id"=>"M8089", "name"=>"Esophageal Perforation", "asFound"=>"Esophageal Perforation", "relevance"=>"HIGH"}, {"id"=>"M4453", "name"=>"Arrhythmias, Cardiac", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}, {"id"=>"M8085", "name"=>"Esophageal Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Randomized, open label"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>150}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-02-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-07-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-07-04", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Thermal injury detected during post-procedural endoscopy", "timeFrame"=>"Post-procedural endoscopy was performed within 15 days after the procedure.", "description"=>"Composite of esophageal ulcer or erosion and gastric hypomotility."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Pulmonary Vein Isolation", "PVI", "HPSD", "High Power Short Duration", "Esophageal injury"], "conditions"=>["Atrial Fibrillation (AF)", "Esophageal Perforation", "Esophageal Perforation, Traumatic"]}, "descriptionModule"=>{"briefSummary"=>"Pulmonary vein isolation (PVI) is the most effective means of maintaining sinus rhythm in atrial fibrillation (AF), while a widely used approach to PVI is point-by-point radiofrequency (RF) catheter ablation. High power short duration (HPSD) and very high power short duration e.g., 90W and 4 sec) are increasingly popular technologies, featuring higher power and shorter application durations compared to previous methods. vHPSD offers similar efficacy to HPSD, while further reducing procedure times. Atrioesophageal fistula (AEF) is a rare but deadly complication of PVI, while endoscopically detected esophageal lesions are surrogate markers for the risk of AEF. Furthermore, thermal complications include vagal lesions leading to gastroparesis. While there is considerable data on the thermal safety of HPSD technology, most studies of vHPSD focus on efficacy and a direct comparison in terms of esophageal safety is lacking. In this randomized, single-center study, we aim to compare the thermal safety of vHPSD to HPSD. Furthermore, we aimed to determine the anatomical and biophysical factors that predict thermal injury. Patients undergoing their first PVI for AF are randomized to either HPSD or vHPSD power setting. The primary endpoint of the study is the composite of esophageal mucosal lesion and gastroparesis, as assessed at the post-procedural endoscopy within 15 days after the PVI."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n- Patients with paroxysmal or persistent atrial fibrillation undergoing their first pulmonary vein isolation procedure\n\nExclusion Criteria:\n\n* Additional ablation performed outside PVI\n* Contraindications to postoperative upper endoscopy"}, "identificationModule"=>{"nctId"=>"NCT06617442", "acronym"=>"HPSD-Esophagus", "briefTitle"=>"Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings", "organization"=>{"class"=>"OTHER", "fullName"=>"Semmelweis University"}, "officialTitle"=>"Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings", "orgStudyIdInfo"=>{"id"=>"8088-2/2022/EÜIG"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"90W", "description"=>"Pulmonary vein isolation performed using very-high power short duration applications (90-watt applications lasting 4 seconds).", "interventionNames"=>["Procedure: Pulmonary vein isolation"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"50W", "description"=>"Pulmonary vein isolation performed using high power short duration applications (50-watt applications guided by ablation index).", "interventionNames"=>["Procedure: Pulmonary vein isolation"]}], "interventions"=>[{"name"=>"Pulmonary vein isolation", "type"=>"PROCEDURE", "description"=>"First pulmonary vein isolation performed for atrial fibrillation.", "armGroupLabels"=>["50W", "90W"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"1122", "city"=>"Budapest", "country"=>"Hungary", "facility"=>"Semmelweis University Heart and Vascular Center", "geoPoint"=>{"lat"=>47.49801, "lon"=>19.03991}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Semmelweis University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor", "investigatorFullName"=>"Nandor Szegedi", "investigatorAffiliation"=>"Semmelweis University"}}}}
