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Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration (CIRCA-DOSE)

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ClinicalTrials.gov Identifier: NCT01913522
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Andrade, University of British Columbia

Study Description
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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 ablation, which is centered on electrical isolation of triggering foci within the pulmonary veins (PVI) through circumferential lesions around PV ostia, has been shown to result in sustained improvements in quality of life, decreased hospitalizations and, potentially, improved survival.2-4 PVI can be accomplished by percutaneous catheter-based thermo-coagulation (burning) with radiofrequency (RF) energy delivery or alternatively by thermo-cooling (freezing) with a cryoballoon catheter.5 Cryothermal ablation with a cryoballoon catheter offers an efficacious means to achieve PVI that is safer than the established technique. Although cryoballoon ablation has been used in clinical practice for sometime, the optimal duration of cryoballoon ablation has not been determined. Moreover, the biophysics of cryo-lesion formation suggests that repeated short freezes ("freeze-thaw-freeze" cycles) may be more efficacious in achieving deep homogenous lesion when compared to prolonged freezing durations. This grant proposal is to verify if repeated short freezing cycles are more efficacious (i.e., fewer recurrence of AF), and safer, than the established standard of long, single freeze cycles.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Procedure: Pulmonary Vein Isolation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: The Effect of Double Short vs. Standard Exposure Cryoablation Duration During Pulmonary Vein Isolation.
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : March 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Standard cryoablation
Patients randomized to the standard group will undergo cryoablation with target duration of 240 seconds. Once PVI is achieved a single "bonus" application of 240 seconds will be delivered after the rewarming phase (to +20oC).
 Procedure: Pulmonary Vein Isolation
Active Comparator: Irrigated RF Ablation
Patients randomized to irrigated RF group will undergo standard wide circumferential PVI with an irrigated radiofrequency catheter
 Procedure: Pulmonary Vein Isolation
Experimental: Short Cryoablation
Patients randomized to the multiple-freeze group will undergo cryoablation with target duration of 120 seconds. Once PVI is achieved a single "bonus" application of 120 seconds will be delivered after the rewarming phase (to +20oC).
 Procedure: Pulmonary Vein Isolation


Outcome Measures
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Primary Outcome Measures :
  1. Time to first recurrence of AF, atrial flutter, or left atrial tachycardia documented by 12-lead ECG, surface ECG rhythm strips, ambulatory ECG monitor, or implantable loop recorder and lasting 30 seconds or longer [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to first recurrence of symptomatic electrocardiographically documented AF/AFL/AT between days 91 and 365 after ablation [ Time Frame: 1 year ]
  2. Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF) [ Time Frame: 1 year ]
  3. Repeat ablation procedure because of documented recurrence of symptomatic AF/AFL/AT [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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 Criteria:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913522


Locations
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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jason Andrade, MD University of British Columbia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jason Andrade, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01913522    
Other Study ID Numbers: H13-01689
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes