Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Jason Andrade
- Enrollment
- 135
- Locations
- 6
- Primary Endpoint
- Total time required for left atrial access
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Detailed Description
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. Trial 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. Study Population - The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Investigators
Jason Andrade
MD FRCPC FHRS
University of British Columbia
Eligibility Criteria
Inclusion Criteria
- •Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
- •Age of 18 years or older on the date of consent
- •Candidate for ablation based on AF that is symptomatic
- •Informed Consent
Exclusion Criteria
- •Previous left atrial (LA) ablation or LA surgery
- •AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- •Active Intracardiac Thrombus
- •Pre-existing pulmonary vein stenosis or PV stent
- •Pre-existing hemidiaphragmatic paralysis
- •Contraindication to anticoagulation or radiocontrast materials
- •Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
- •Cardiac valve prosthesis
- •Clinically significant (moderately-severe, or severe) mitral valve regurgitation or stenosis
- •Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date
Outcomes
Primary Outcomes
Total time required for left atrial access
Time Frame: Intraprocedural assessment (within 24 hours)
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.
Secondary Outcomes
- Plastic Shavings(Intraprocedural assessment of visible plastic shavings (within 24 hours))
- Transseptal time - left atrial access to sheath positioning(Intraprocedural assessment (measured in seconds))
- Transeptal Access(Intraprocedural assessment (within 24 hours))
- The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture(Acute peri-procedural complications will be defined as occurring within 30 days of ablation)
- Transseptal time - septal engagement to sheath advancement(Intraprocedural assessment (measured in seconds))