Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT01629056
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2012-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Contact PVI Study: Use of Tissue Contact Data to Guide Atrial Fibrillation Ablation
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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure will be the proportion (%) of pulmonary vein pairs found to be reconnected electrically to the left atrium at a subsequent redo ablation procedure', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Proportion of acute venous electrical reconnections', 'timeFrame': 'acute (intra-procedure)', 'description': 'proportion of pulmonary veins found to be electrically reconnected to the left atrium at the end of the index procedure'}, {'measure': 'touch-up ablation requirements', 'timeFrame': 'acute (intra-procedure)', 'description': 'proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure'}, {'measure': 'procedure time', 'timeFrame': 'acute', 'description': 'duration of procedure'}, {'measure': 'RF time', 'timeFrame': 'acute (intra-procedure)', 'description': 'total amount of radiofrequency ablation required'}, {'measure': 'anatomical location of reconnections at repeat procedure', 'timeFrame': 'at repeat ablation procerdure (6-12 months post index ablation procedure)', 'description': 'anatomical location of electrical reconnections in pulmonary vein antra, as measured at a repeat ablation procedure'}, {'measure': 'amount of RF required to achieve re-isolation at repeat ablation procedure', 'timeFrame': 'at repeat ablation procedure (6-12 months post-index ablation procedure)', 'description': 'total time of RF delivery required to re-isolate the reconnected pulmonary veins at a repeat ablation procedure'}, {'measure': 'complications', 'timeFrame': 'acute and subacute (intra-procedure, and during entire follow-up period)', 'description': 'procedure-related complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'ablation', 'contact'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the benefit of a new impedance-based computer software application during routine catheter ablation for atrial fibrillation, to see if this information improves short and long term electrical disconnection of the pulmonary veins. This study will be a single blind prospective randomised control trial in patients undergoing AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary vein ablation with, and parts of their ablation without tissue contact data displayed for the doctor performing the ablation to see. The pulmonary veins will then be studied at the end of the procedure, and at any repeat procedure in the future, to look for a difference in the recovery rate of the ablations performed using contact data, compared to those ablations performed without the use of this contact data. If a reduction in tissue recovery is achieved through the use of this tissue contact data, it may lead in the future to a reduced need for repeat ablation procedures, and better outcomes for patients.\n\nThe investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing left atrial ablation for atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is undergoing de novo pulmonary vein isolation procedure.\n2. Participant is willing and able to give informed consent for participation in the study.\n3. Male or Female, ≥18 years of age.\n\nExclusion Criteria:\n\n1. Previous percutaneous or open surgical procedure involving the left atrium\n2. Pregnancy (current or currently planning)'}, 'identificationModule': {'nctId': 'NCT01629056', 'briefTitle': 'The Contact PVI Study: Use of Tissue Contact Data to Guide Atrial Fibrillation Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'The Contact-PVI Study - Does Assessment of Tissue Contact During RF Ablation Using the St. Jude Medical™ Ensite™ Contact™ System Increase Rates of Long-term Pulmonary Vein Isolation? A Prospective Randomised Study', 'orgStudyIdInfo': {'id': '77431/244334/1/228'}, 'secondaryIdInfos': [{'id': '11/SC/0398', 'type': 'OTHER', 'domain': 'Oxford C NRES Committee South Central'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Contact ECI active', 'description': 'Contact ECI active', 'interventionNames': ['Procedure: ablation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Contact information deactivated', 'description': 'RF ablation without contact data', 'interventionNames': ['Procedure: RF ablation']}], 'interventions': [{'name': 'ablation', 'type': 'PROCEDURE', 'otherNames': ['Irrigated RF ablation', 'RF ablation', 'Percutaneous transvenous catheter ablation'], 'description': 'RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)', 'armGroupLabels': ['Contact ECI active']}, {'name': 'RF ablation', 'type': 'PROCEDURE', 'otherNames': ['Irrigated RF ablation', 'Percutaneous transvenous catheter ablation'], 'description': 'RF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm)', 'armGroupLabels': ['Contact information deactivated']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Ox39DU', 'city': 'Headington', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75737, 'lon': -1.21974}}], 'overallOfficials': [{'name': 'Michael A Jones, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}, {'name': 'Tim R Betts, MbCHb PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}