Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 7:18 PM
Study NCT ID:
NCT00969735
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2009-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-01', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-08-31', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients without AF recurrences longer than 2 minutes', 'timeFrame': 'At the 12th month from ablation (using a blanking period of 3 months following ablation)'}], 'secondaryOutcomes': [{'measure': 'Time to first AF recurrence longer than 2 minutes', 'timeFrame': 'Within the first 12 months from ablation (using a blanking period of 3 months following ablation, and without the use of any blanking period)'}, {'measure': 'Cumulative burden of AF (number of AF episodes longer than 2 minutes)', 'timeFrame': 'At the 12th month from ablation (using a blanking period of 3 months following ablation)'}, {'measure': 'Cumulative burden of AF (percentage of time in AF)', 'timeFrame': 'At the 12th month from ablation (using a blanking period of 3 months following ablation)'}, {'measure': 'Proportion of patients with episodes of regular atrial tachycardia or atrial flutter requiring treatment with drugs, electrical cardioversion or ablation.', 'timeFrame': 'Within the first 12 months from ablation'}, {'measure': 'Quality of Life and symptom status', 'timeFrame': 'At the 12th month from ablation'}, {'measure': 'Proportion of patients with procedure-related complications', 'timeFrame': 'Within the first 12 months from ablation'}, {'measure': 'Procedure time (minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter)', 'timeFrame': 'At the end of the ablation procedure'}, {'measure': 'Ablation time (minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery).', 'timeFrame': 'At the end of the ablation procedure'}, {'measure': 'Fluoroscopy time (minutes of fluoroscopy used during the entire ablation procedure)', 'timeFrame': 'At the end of the ablation procedure'}, {'measure': 'Proportion of pulmonary veins remaining isolated', 'timeFrame': 'At the end of the ablation procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Catheter ablation', 'Cryoenergy', 'Implantable loop recorder', 'Pulmonary vein'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.', 'detailedDescription': 'Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they require precise catheter manipulation and multiple radiofrequency applications. Thus, alternative techniques are being investigated to simplify the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it can create a circumferential lesion around the PV ostium by delivering a single cryoenergy application.\n\nAn implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.\n\nThis is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic recurrent paroxysmal AF (\\>2 episodes in the last 6 months), and\n* Refractory to one or more class I or III antiarrhythmic drugs, and\n* PV anatomy consisting of 4 single PV, with the long diameter of the right superior PV ostium ≤ 20 mm.\n\nExclusion Criteria:\n\n* Age: \\< 18 or \\> 75 year-old\n* Prior AF ablation\n* Pregnancy\n* Concomitant acute illness\n* Hyperthyroidism\n* Moderate to severe valvular heart disease\n* Prior cardiac surgery\n* Left atrium \\> 50 mm (anteroposterior diameter, parasternal long-axis view)\n* Intracardiac thrombus\n* Contraindications for anticoagulant therapy\n* Inability to be followed in our center for at least 1 year'}, 'identificationModule': {'nctId': 'NCT00969735', 'acronym': 'COR', 'briefTitle': 'Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': 'Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation (COR Trial)', 'orgStudyIdInfo': {'id': 'COR-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cryoablation', 'description': 'Deflectable over-the-wire cryoablation balloon catheter (Arctic Front®, Cryocath Technologies)', 'interventionNames': ['Device: Pulmonary vein cryoablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiofrequency ablation', 'description': 'Open irrigation ablation catheter (Navistar® Thermo-cool®, Biosense Webster Inc).', 'interventionNames': ['Device: Pulmonary vein radiofrequency ablation']}], 'interventions': [{'name': 'Pulmonary vein cryoablation', 'type': 'DEVICE', 'otherNames': ['Cryoenergy balloon catheter ablation'], 'description': 'A deflectable over-the-wire cryoablation balloon catheter (Arctic Front®) will be inflated and be positioned at each PV antrum. Then, cryoenergy will be delivered for 300 seconds. During cryoablation of the right PVs, the right phrenic nerve integrity will be monitored by the observation of right hemi-diaphragm contractions in response to right phrenic nerve pacing at the superior vena cava. Once the 4 PVs are cryoablated, the Arctic Front® catheter will be replaced by a decapolar PV mapping circular catheter (Lasso®, Biosense Webster, Diamond Bar, California, EEUU) to evaluate PV conduction. A second cryoablation application may be delivered at each PV, if necessary. Crossover to RF ablation to complete PV isolation is discouraged.', 'armGroupLabels': ['Cryoablation']}, {'name': 'Pulmonary vein radiofrequency ablation', 'type': 'DEVICE', 'otherNames': ['Pulmonary vein isolation'], 'description': 'Ablation approach is ostial electrical isolation of all PVs with simultaneous use of the CARTO® electroanatomic mapping system (Biosense Webster, Tirat-Ha-Carmel, Israel). PV isolation will be performed by delivering RF energy at ostial sites with earliest PV potentials. Flow rate during the RF applications will be set at 15 mL/min (baseline 2 mL/min). Temperature and power limits will be set at 45ºC and 35 W. It will be allowed a 5 W reduction in power limit setting for small PVs (angiographic supero-inferior diameter \\> 12 mm), and a 5 W increase in areas located away from the esophagus, and for focal applications at sites resistant to ablation or recurrent gaps. The end-point of ablation will be to achieve bidirectional PV conduction block.', 'armGroupLabels': ['Radiofrequency ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Unidad de Arritmias, Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Nicasio Pérez Castellano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidad de Arritmias, Hospital Clínico San Carlos, Madrid, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Society of Cardiology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Nicasio Perez Castellano', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}}