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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Pulmonary Vein Isolation

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Standard cryoablation

Irrigated RF Ablation

Short Cryoablation

Arm Description

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).

Patients randomized to irrigated RF group will undergo standard wide circumferential PVI with an irrigated radiofrequency catheter

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first recurrence of symptomatic electrocardiographically documented AF/AFL/AT between days 91 and 365 after ablation

Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF)

Repeat ablation procedure because of documented recurrence of symptomatic AF/AFL/AT

Full Information

NCT ID

NCT01913522

First Posted

July 30, 2013

Last Updated

May 3, 2019

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01913522

Brief Title

Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration

Acronym

CIRCA-DOSE

Official Title

Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: The Effect of Double Short vs. Standard Exposure Cryoablation Duration During Pulmonary Vein Isolation.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

September 2014 (Actual)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

348 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard cryoablation

Arm Type

Experimental

Arm Description

Arm Title

Irrigated RF Ablation

Arm Type

Active Comparator

Arm Description

Patients randomized to irrigated RF group will undergo standard wide circumferential PVI with an irrigated radiofrequency catheter

Arm Title

Short Cryoablation

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Pulmonary Vein Isolation

Primary Outcome Measure Information:

Title

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time to first recurrence of symptomatic electrocardiographically documented AF/AFL/AT between days 91 and 365 after ablation

Time Frame

1 year

Title

Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF)

Time Frame

1 year

Title

Repeat ablation procedure because of documented recurrence of symptomatic AF/AFL/AT

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Andrade, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

34816727

Citation

Aguilar M, Macle L, Deyell MW, Yao R, Hawkins NM, Khairy P, Andrade JG. Influence of Monitoring Strategy on Assessment of Ablation Success and Postablation Atrial Fibrillation Burden Assessment: Implications for Practice and Clinical Trial Design. Circulation. 2022 Jan 4;145(1):21-30. doi: 10.1161/CIRCULATIONAHA.121.056109. Epub 2021 Nov 24.

Results Reference

derived

PubMed Identifier

34406350

Citation

Samuel M, Khairy P, Champagne J, Deyell MW, Macle L, Leong-Sit P, Novak P, Badra-Verdu M, Sapp J, Tardif JC, Andrade JG. Association of Atrial Fibrillation Burden With Health-Related Quality of Life After Atrial Fibrillation Ablation: Substudy of the Cryoballoon vs Contact-Force Atrial Fibrillation Ablation (CIRCA-DOSE) Randomized Clinical Trial. JAMA Cardiol. 2021 Nov 1;6(11):1324-1328. doi: 10.1001/jamacardio.2021.3063.

Results Reference

derived

PubMed Identifier

33634706

Citation

Tang LYW, Hawkins NM, Ho K, Tam R, Deyell MW, Macle L, Verma A, Khairy P, Sheldon R, Andrade JG; CIRCA-DOSE Study Investigators. Autonomic Alterations After Pulmonary Vein Isolation in the CIRCA-DOSE (Cryoballoon vs Irrigated Radiofrequency Catheter Ablation) Study. J Am Heart Assoc. 2021 Feb;10(5):e018610. doi: 10.1161/JAHA.120.018610. Epub 2021 Feb 26.

Results Reference

derived

PubMed Identifier

32819529

Citation

Yao RJR, Macle L, Deyell MW, Tang L, Hawkins NM, Sedlak T, Nault I, Verma A, Khairy P, Andrade JG; CIRCA-DOSE Study Investigators. Impact of Female Sex on Clinical Presentation and Ablation Outcomes in the CIRCA-DOSE Study. JACC Clin Electrophysiol. 2020 Aug;6(8):945-954. doi: 10.1016/j.jacep.2020.04.032. Epub 2020 Jul 29.

Results Reference

derived

PubMed Identifier

32819528

Citation

Andrade JG, Macle L, Verma A, Deyell MW, Champagne J, Dubuc M, Leong-Sit P, Novak P, Roux JF, Sapp J, Khoo C, Rizkallah J, Levesque S, Tang ASL, Khairy P; CIRCA-DOSE Study Investigators. Quality of Life and Health Care Utilization in the CIRCA-DOSE Study. JACC Clin Electrophysiol. 2020 Aug;6(8):935-944. doi: 10.1016/j.jacep.2020.04.017.

Results Reference

derived

PubMed Identifier

32614422

Citation

Andrade JG, Deyell MW, Verma A, Macle L, Champagne J, Leong-Sit P, Novak P, Badra-Verdu M, Sapp J, Khairy P, Nattel S. Association of Atrial Fibrillation Episode Duration With Arrhythmia Recurrence Following Ablation: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Jul 1;3(7):e208748. doi: 10.1001/jamanetworkopen.2020.8748.

Results Reference

derived

PubMed Identifier

32371199

Citation

Andrade JG, Yao RRJ, Deyell MW, Hawkins NM, Rizkallah J, Jolly U, Khoo C, Raymond JM, McKinney J, Cheung C, Steinberg C, Ha A, Ramanathan K, Luong C, Glover B, Verma A, Macle L, Khairy P; CIRCA-DOSE Study Investigators. Clinical assessment of AF pattern is poorly correlated with AF burden and post ablation outcomes: A CIRCA-DOSE sub-study. J Electrocardiol. 2020 May-Jun;60:159-164. doi: 10.1016/j.jelectrocard.2020.03.008. Epub 2020 Mar 21.

Results Reference

derived

PubMed Identifier

31978593

Citation

Andrade JG, Deyell MW, Nattel S, Khairy P, Dubuc M, Champagne J, Leong-Sit P, Jolly U, Badra-Verdu M, Sapp J, Verma A, Macle L; CIRCA-DOSE Study Investigators. Prevalence and clinical impact of spontaneous and adenosine-induced pulmonary vein reconduction in the Contact-Force vs. Cryoballoon Atrial Fibrillation Ablation (CIRCA-DOSE) study. Heart Rhythm. 2020 Jun;17(6):897-904. doi: 10.1016/j.hrthm.2020.01.017. Epub 2020 Jan 21.

Results Reference

derived

PubMed Identifier

31630538

Citation

Andrade JG, Champagne J, Dubuc M, Deyell MW, Verma A, Macle L, Leong-Sit P, Novak P, Badra-Verdu M, Sapp J, Mangat I, Khoo C, Steinberg C, Bennett MT, Tang ASL, Khairy P; CIRCA-DOSE Study Investigators. Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial. Circulation. 2019 Nov 26;140(22):1779-1788. doi: 10.1161/CIRCULATIONAHA.119.042622. Epub 2019 Oct 21.

Results Reference

derived

PubMed Identifier

28982836

Citation

Andrade JG, Deyell MW, Badra M, Champagne J, Dubuc M, Leong-Sit P, Macle L, Novak P, Roux JF, Sapp J, Tang A, Verma A, Wells GA, Khairy P. Randomised clinical trial of cryoballoon versus irrigated radio frequency catheter ablation for atrial fibrillation-the effect of double short versus standard exposure cryoablation duration during pulmonary vein isolation (CIRCA-DOSE): methods and rationale. BMJ Open. 2017 Oct 5;7(10):e017970. doi: 10.1136/bmjopen-2017-017970.

Results Reference

derived

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Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration

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