Status:
COMPLETED
Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration
Lead Sponsor:
University of British Columbia
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with reductions in quality of life, functional status, cardiac performance, and overall survival.1 Catheter a...
Eligibility Criteria
Inclusion
- \- Non-permanent atrial fibrillation documented on a 12 lead ECG, TTM or Holter monitor within the last 12 months Low Burden Paroxysmal - ≥2 episodes of AF over the past 12 months; Episodes terminate spontaneously within 7 days or via cardioversion within 48 hours of onset.
- High Burden Paroxysmal - ≥4 episodes of AF over the past 6 months, with ≥2 episodes \>6 hours in duration; Episodes terminate spontaneously within 7 days or via cardioversion within 48 hours of onset.
- Early Persistent - ≥2 episodes of AF over the past 12 months; Episodes are successfully terminated via cardioversion within 7 days of onset.
- Age of 18 years or older on the date of consent
- Candidate for ablation based on AF that is symptomatic and refractory (ineffective or intolerant) to at least one class 1 or 3 antiarrhythmic
- Continuous anticoagulation with warfarin (INR 2-3), low molecular weight heparin, or a novel oral antithrombotic (dabigatran, apixaban, rivaroxaban) for ≥4 weeks prior to the ablation; or a TEE that excludes LA thrombus ≤48 hours before ablation
- Informed Consent Form
Exclusion
- Previous left atrial (LA) ablation or LA surgery
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Anteroposterior LA diameter greater than 5.5 cm by TTE
- 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
- Cardiac surgery during the three-month interval preceding the consent date
- Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) less than 35%
- Hypertrophic cardiomyopathy
- Significant CKD (eGFR \<30 mL/min/m2)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
- Subject known to be pregnant
- Life expectancy less than one (1) year
- Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic during the duration of this study
- Unwilling or unable to comply fully with study procedures and follow-up
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT01913522
Start Date
September 1 2014
End Date
March 1 2019
Last Update
May 7 2019
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada