Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-02 @ 9:46 AM
Study NCT ID:
NCT03199703
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Versus RF Needle Transseptal Puncture for Cryoballoon 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total time required for left atrial access', 'timeFrame': 'Intraprocedural assessment (within 24 hours)', 'description': 'defined as time from the first pull-down of the needle/sheath/dilator apparatus in the superior vena cava to first entrance of the cryoballoon into the left atrium.'}], 'secondaryOutcomes': [{'measure': 'Transeptal Access', 'timeFrame': 'Intraprocedural assessment (within 24 hours)', 'description': 'Success/failure of the assigned transseptal apparatus to achieve transeptal puncture (proportion of patients necessitating the use of the alternate study apparatus - e.g. cross-over from the NRG RF needle to the to conventional BRK needle)'}, {'measure': 'Plastic Shavings', 'timeFrame': 'Intraprocedural assessment of visible plastic shavings (within 24 hours)', 'description': 'Proportion of cases whereby the presence (or absence) of visible plastic dilator shavings from needle introduction are seen'}, {'measure': 'The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture', 'timeFrame': 'Acute peri-procedural complications will be defined as occurring within 30 days of ablation', 'description': 'Events include pericardial effusion, pericardial tamponade, cardiac perforation, air embolism, aortic root puncture'}, {'measure': 'Transseptal time - septal engagement to sheath advancement', 'timeFrame': 'Intraprocedural assessment (measured in seconds)', 'description': 'Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA'}, {'measure': 'Transseptal time - left atrial access to sheath positioning', 'timeFrame': 'Intraprocedural assessment (measured in seconds)', 'description': 'Time from needle advancement through the septum to sheath advancement into the LA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PVI Ablation', 'Cryoballoon'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '35739438', 'type': 'DERIVED', 'citation': 'Andrade JG, Macle L, Bennett MT, Hawkins NM, Essebag V, Champagne J, Roux JF, Makanjee B, Tang A, Skanes A, Khaykin Y, Morillo C, Jolly U, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Wells GA, Verma A, Deyell MW. Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial. J Interv Card Electrophysiol. 2022 Nov;65(2):481-489. doi: 10.1007/s10840-022-01277-y. Epub 2022 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.\n\nThe targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.', 'detailedDescription': 'Study Objective - The objective of the prospective, randomized study is to evaluate the effectiveness and safety of the Baylis transseptal system (RF needle, TorFlex sheath, and specialised ProTrack guidewire) compared with a conventional transseptal (conventional sheath, Brockenbrough needle, and standard guidewire) for transseptal LA access during cryoballoon ablation procedures.\n\nTrial design - This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.\n\nStudy Population - The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months\n* Age of 18 years or older on the date of consent\n* Candidate for ablation based on AF that is symptomatic\n* Informed Consent\n\nExclusion Criteria:\n\n* Previous left atrial (LA) ablation or LA surgery\n* AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)\n* Active Intracardiac Thrombus\n* Pre-existing pulmonary vein stenosis or PV stent\n* Pre-existing hemidiaphragmatic paralysis\n* Contraindication to anticoagulation or radiocontrast materials\n* Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography\n* Cardiac valve prosthesis\n* Clinically significant (moderately-severe, or severe) mitral valve regurgitation or stenosis\n* Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date\n* Cardiac surgery during the three-month interval preceding the consent date\n* Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)\n* NYHA class III or IV congestive heart failure\n* Left ventricular ejection fraction (LVEF) less than 35%\n* Hypertrophic cardiomyopathy (septal or posterior wall thickness \\>1.5 cm)\n* Significant Chronic Kidney Disease (CKD - eGFR \\<30 µMol/L)\n* Uncontrolled hyperthyroidism\n* Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date\n* Pregnancy\n* Life expectancy less than one (1) year\n* Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study\n* Unwilling or unable to comply fully with study procedures and follow-up'}, 'identificationModule': {'nctId': 'NCT03199703', 'acronym': 'CRYO-LATS', 'briefTitle': 'Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation', 'orgStudyIdInfo': {'id': '6-May-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Baylis transseptal system group', 'description': 'Patients randomized to the Baylis transseptal system group (Bayliss Group) will undergo transseptal puncture with a large, preformed curve 71-cm-C1 or 98-cm-C1 18-gauge NRG needle (Baylis Medical) through a TorFlex sheath (Baylis Medical), with the sheath curve selected at the discretion of the operating physician.', 'interventionNames': ['Device: Baylis transseptal system group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional transseptal group', 'description': 'Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with either a large, preformed curve 71- or 98-cm 18-gauge BRK needle (BRK, BRK-1, BRK-2 needle, St. Jude Medical) through any non-Baylis sheath (for example Schwartz SL, Biosense-Webster Preface) selected at the discretion of the operating physician.', 'interventionNames': ['Device: Standard conventional transseptal group']}], 'interventions': [{'name': 'Baylis transseptal system group', 'type': 'DEVICE', 'armGroupLabels': ['Baylis transseptal system group']}, {'name': 'Standard conventional transseptal group', 'type': 'DEVICE', 'armGroupLabels': ['Conventional transseptal group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital, University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jason Andrade', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylis Medical Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD FRCPC FHRS', 'investigatorFullName': 'Jason Andrade', 'investigatorAffiliation': 'University of British Columbia'}}}}