Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT03716934
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2018-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial
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': 'D000889', 'term': 'Anti-Arrhythmia Agents'}], 'ancestors': [{'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2018-10-15', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival time with atrial fibrilation, auricular flutter or tachycardia', 'timeFrame': 'Up to 9 months.', 'description': 'Survival time without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes duration detected by Holter'}, {'measure': 'Presence of death or one major complications.', 'timeFrame': 'first month', 'description': 'Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of pulmonary veins, Sustained (\\> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.'}, {'measure': 'Presence of death or one major complications.', 'timeFrame': 'fourth month', 'description': 'Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of pulmonary veins, Sustained (\\> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.'}, {'measure': 'Presence of death or one major complications.', 'timeFrame': 'thirteen month', 'description': 'Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of VP, Sustained (\\> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients without atrial fibrilation, flutter or tachycardia', 'timeFrame': 'first month', 'description': 'Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes'}, {'measure': 'Percentage of patients without atrial fibrilation, flutter or tachycardia', 'timeFrame': 'fourth month', 'description': 'Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes'}, {'measure': 'Percentage of patients without atrial fibrilation, flutter or tachycardia', 'timeFrame': 'thirteen month', 'description': 'Number of patients without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes'}, {'measure': 'Percentage of patient with cardioversion', 'timeFrame': 'first month', 'description': 'Number of patients that need cardioversion'}, {'measure': 'Percentage of patient with cardioversion', 'timeFrame': 'fourth month', 'description': 'Number of patients that need cardioversion'}, {'measure': 'Percentage of patient with cardioversion', 'timeFrame': 'thirteen month', 'description': 'Number of patients that need cardioversion'}, {'measure': 'Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events', 'timeFrame': 'first month', 'description': 'Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events'}, {'measure': 'Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events', 'timeFrame': 'fourth month', 'description': 'Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events'}, {'measure': 'Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events', 'timeFrame': 'thirteen month', 'description': 'Number of patients that need to consult the emergency room or hospitalization due to cardiovascular events'}, {'measure': 'Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency', 'timeFrame': 'first month', 'description': 'Number of patients that need a change or suspension of antiarrhythmic due to inefficiency'}, {'measure': 'Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency', 'timeFrame': 'fourth month', 'description': 'Number of patients that need a change or suspension of antiarrhythmic due to inefficiency'}, {'measure': 'Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency', 'timeFrame': 'thirteen month', 'description': 'Number of patients that need a change or suspension of antiarrhythmic due to inefficiency'}, {'measure': 'Percentage of patient with need for ablation or re-ablation not scheduled', 'timeFrame': 'first month', 'description': 'Number of patients that need a ablation or re-ablation not scheduled'}, {'measure': 'Percentage of patient with need for ablation or re-ablation not scheduled', 'timeFrame': 'fourth month', 'description': 'Number of patients that need a ablation or re-ablation not scheduled'}, {'measure': 'Percentage of patient with need for ablation or re-ablation not scheduled', 'timeFrame': 'thirteen month', 'description': 'Number of patients that need a ablation or re-ablation not scheduled'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, multicenter study comparing the relative efficacy and safety of cryoablation of PVs using the Arctic Front Advance® balloon catheter with antiarrhythmic therapy in patients with persistent AF.', 'detailedDescription': 'The ablation of pulmonary veins is a very effective treatment for the treatment of paroxysmal atrial fibrillation. The benefit of the isolation of pulmonary veins in persistent atrial fibrillation seems to be minor and the level of scientific evidence available requires additional clinical trials to define the value of ablation in this type of patients.\n\nThe symptomatology of atrial fibrillation recurrences is variable among patients and among differens moments in the same patient. Pharmacological treatment and ablation have been used to reduce the symptomatology of atrial fibrillation recurrences and to increase the proportion of asymptomatic recurrences. Different forms of electrical monitoring of the heart rate are used to evaluate the effectiveness of an intervention. Frequents monitoring periods provide the information of the heart rate and the effect of any intervention.\n\nThe "Confirm RX heart monitor® (Abbott)" is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function. This implantable Holter automatically detects and saves atrial and ventricular arrhythmic episodes. The device can be analyzed in person or remotely, and can help to make decisions regarding anticoagulant and antiarrhythmic treatment of patients, while representing a powerful research tool for evaluate the effectiveness of different therapeutic options.\n\nThis is a prospective, randomized, multicenter study that compares the relative efficacy and safety of cryoablation of pulmonary veins using the Arctic Front Advance® balloon catheter with antiarrhythmic treatment in patients with persistent atrial fibrilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recurrent persistent atrial fibrilation\n\nExclusion Criteria:\n\n* Patients with atrial fibrilation for more than one year at baseline\n* Atrial fibrilation prior ablation\n* Age\\> 75 years or \\<18 years\n* Hyperthyroidism\n* Hypertrophic cardiomyopathy\n* Severe valvular disease (stenosis or regurgitation)\n* Carriers of cardiac valves\n* Anteroposterior diameter of left atrium\\> 50 mm (left parasternal long axis)\n* Contraindications for anticoagulation\n* Left atrial thrombus\n* Anemia\n* Active infection\n* Pregnancy\n* Atrial fibrilation secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...)\n* Life expectancy of less than 24 months\n* Participation in another non-purely observational study\n* Patients unable to understand treatment and / or study and / or providing adequate informed consent\n* Any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study\n* Microalbuminemia'}, 'identificationModule': {'nctId': 'NCT03716934', 'acronym': 'craft', 'briefTitle': 'CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': 'CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial', 'orgStudyIdInfo': {'id': '17/507-R_M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryoablation', 'description': 'Cryoablation for bidirectional block of all pulmonary veins', 'interventionNames': ['Device: Arctic Front Advance® balloon catheter', 'Device: Confirm RX heart monitor® (Abbott)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antiarrythmics', 'description': 'The drug will be chosen based on the preference of the researcher based on clinical practice guidelines.', 'interventionNames': ['Drug: Antiarrhythmic drug', 'Device: Confirm RX heart monitor® (Abbott)']}], 'interventions': [{'name': 'Arctic Front Advance® balloon catheter', 'type': 'DEVICE', 'description': 'Cryoablation of bidirectional block of all pulmonary veins', 'armGroupLabels': ['Cryoablation']}, {'name': 'Antiarrhythmic drug', 'type': 'DRUG', 'otherNames': ['Class I or III'], 'description': 'The drug will be chosen based on the preference of the researcher / responsible physician and current clinical practice guidelines.', 'armGroupLabels': ['Antiarrythmics']}, {'name': 'Confirm RX heart monitor® (Abbott)', 'type': 'DEVICE', 'description': 'Is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function', 'armGroupLabels': ['Antiarrythmics', 'Cryoablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion para Investigación Biomedica Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicasio Perez Castellano', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}}