Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT01144858
Status:
TERMINATED
Last Update Posted:
2010-06-16
First Post:
2010-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': '40 patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-15', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'termination of persistent AF by catheter ablation'}], 'secondaryOutcomes': [{'measure': 'Recurrences of AF were therefore determined from holter monitoring at 3 and 6 months or 12 leads ECG in care of symptomatic palpitation with clinical interview.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'ablation catheter', 'left atrial appendage peak emptying velocity', 'tool for predicting successful catheter ablation'], 'conditions': ['Persistent Atrial Fibrillation', 'Catheter Ablation']}, 'referencesModule': {'references': [{'pmid': '23374970', 'type': 'DERIVED', 'citation': 'Combes S, Jacob S, Combes N, Karam N, Chaumeil A, Guy-Moyat B, Treguer F, Deplagne A, Boveda S, Marijon E, Albenque JP. Predicting favourable outcomes in the setting of radiofrequency catheter ablation of long-standing persistent atrial fibrillation: a pilot study assessing the value of left atrial appendage peak flow velocity. Arch Cardiovasc Dis. 2013 Jan;106(1):36-43. doi: 10.1016/j.acvd.2012.09.002. Epub 2012 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter ablation of persistent Atrial fibrillation( pAF).', 'detailedDescription': '40 PAF patients underwent 3D mapping and ablation. A stepwise approach including circumferential pulmonary vein (PV) isolation, continuous complex-fractionated electrogram (CFE) ablation and linear ablation was performed by the same operator. The procedural end point was termination of persistent AF by catheter ablation, either by conversion directly to sinus rhythm or to atrial tachycardia. Left atrial appendage (LAA) peak flow velocities were measured with transesophageal echography and averaged within each RR interval of 10 consecutive cardiac cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '40 consecutive patients who underwent first-time radiofrequency catheter ablation for pAF. pAF was defined as continuous AF lasting longer than 1 month, resistant to either electrical or pharmacological cardioversion', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-time radiofrequency catheter ablation for pAF. pAF was defined as continuous AF lasting longer than 1 month, resistant to either electrical or pharmacological cardioversion.\n* Informed consent\n\nExclusion Criteria:\n\n* Severe valvular disease requiring surgery\n* Valvular prosthesis\n* Known severe coronary artery disease\n* Atrial and/or ventricular thrombosis\n* New York Heart Association functional class III to IV\n* Cerebrovascular disease\n* Pulmonary embolism\n* Latent or manifest hyperthyroidism'}, 'identificationModule': {'nctId': 'NCT01144858', 'acronym': 'CLAAAF', 'briefTitle': 'Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Pasteur'}, 'officialTitle': 'Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'past-1001-ryth'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with persistent atrial fibrillation ablation', 'interventionNames': ['Other: a complete transesophageal echocardiography']}], 'interventions': [{'name': 'a complete transesophageal echocardiography', 'type': 'OTHER', 'description': 'All patients were evaluated by a complete transesophageal echocardiography with multiplane probes with a 7-MHz transducer before catheter ablation .LA appendage flow was obtained by placing the pulsed Doppler sample volume at the orifice of the LA appendage, after which peak flow velocities were measured and averaged within each RR interval of 10 consecutive cardiac cycles', 'armGroupLabels': ['patients with persistent atrial fibrillation ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31076', 'city': 'Toulouse', 'state': '43-45 Avenue de Lombez', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Pasteur', 'class': 'OTHER'}}}}