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Clinical Trials/NCT03682887
NCT03682887Active, not recruitingNot Applicable

Cryoballoon Pulmonary Vein Isolation vs. Cryoballoon Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Persistent Atrial Fibrillation: Prospective Randomized Trial (CRARAL Trial)

Yonsei University1 site in 1 country195 target enrollmentStarted: November 7, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
195
Locations
1
Primary Endpoint
Recurrence of any atrial arrhythmia
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation. However, it is not certain that cryoablation is effective and safe in patients with persistent atrial fibrillation, because of higher chance of recurrence compared to paroxysmal atrial fibrillation. The aim of this study is to evaluate the efficacy and safety of cryoballoon pulmonary vein isolation vs. cryoballoon pulmonary vein isolation with additional right atrial linear ablation for paroxysmal atrial fibrillation in a prospective randomized trial

Detailed Description

A. Study design

  1. Prospective randomization (cryoballoon PV isolation group vs. cryoballoon PV isolation group with additional RA linear ablation group) (Using the Python program, a random number module is imported with the import random syntax, and the random number table for the two groups is created.)
  2. Target number of subjects: 278 (138 per group)
  3. Rhythm FU : ECG during every visit (1, 3, 6, and 12 months, and then every 6 months thereafter or upon the recurrence of symptoms after AFCA) and 24-h Holter monitor recording at 3 and 6 months and every 6 months thereafter.
  4. Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
  5. All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.

Cryoballoon PV isolation group

  1. Pulmonary vein isolation will be performed using a cryoballoon catheter.
  2. Esophageal temperature will be monitored to prevent esophageal injury.
  3. A 28mm cryoballoon catheter will be used.
  4. Cryoablation will be performed for 180 secs at -30ºC or below on condition that the pulmonary vein is occluded with a cryoballoon.
  5. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
  6. The procedure and ablation times will be evaluated.
  7. The procedure will be completed without checking any other trigger came from beyond pulmonary vein after the administration of isoproterenol
  8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Cryoballoon PV isolation with Additional RA linear ablation group

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient with persistent atrial fibrillation who is scheduled for ablation procedure
  • •≥20 and ≤80 years of age
  • •LA size ≤ 45mm
  • •Patient who is indicated for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drug

Exclusion Criteria

  • •Patients with paroxysmal or permanent atrial fibrillation
  • •Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
  • •Patients with severe renal impairment or CT imaging difficulty using contrast media
  • •Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
  • •Patients with active internal bleeding
  • •Patients with contraindications for anticoagulation therapy (for prevention of cerebral infarction) and antiarrhythmic drugs
  • •Patients with valvular atrial fibrillation (mitral stenosis >grade 2, mechanical valve)
  • •Patients with a severe comorbid disease
  • •Expected survival < 1 year
  • •Drug addicts or alcoholics
  • •Patients who cannot read the consent form (illiterates, foreigners, etc.)
  • •Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study

Arms & Interventions

Cryoballoon PV isolation group

Active Comparator
  1. Pulmonary vein isolation will be performed using a cryoballoon catheter.
  2. Esophageal temperature will be monitored to prevent esophageal injury.
  3. A 28mm cryoballoon catheter will be used.
  4. Cryoablation will be performed for 180 secs at -30 C or below on condition that the pulmonary vein is occluded with a cryoballoon.
  5. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
  6. The procedure and ablation times will be evaluated.
  7. The procedure will be completed without checking any other trigger came from beyond pulmonary vein after the administration of isoproterenol
  8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Intervention: Cryoballoon PV isolation group (Procedure)

Cryoballoon PV isolation w/ RA linear ablation group

Experimental
  1. Pulmonary vein isolation will be performed using a cryoballoon catheter as the same as cryoballoon PV isolation group.
  2. Additional cavo-tricuspid isthmus ablation will be performed with a radiofrequency catheter.
  3. Additional SVC-right atrial septal linear ablation will be performed with a radiofrequency catheter.
  4. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local RF ablation will be followed.
  5. The procedure and ablation times will be evaluated.
  6. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Intervention: Cryoballoon PV isolation with Additional RA linear ablation group (Procedure)

Outcomes

Primary Outcomes

Recurrence of any atrial arrhythmia

Time Frame: up to 24 months with a minimum of 12 months follow up after a single ablation procedure.

Recurrence of any atrial arrhythmia (Defined as atrial fibrillation, atrial tachycardia, or atrial flutter lasting at least 30 seconds after a 3-month post-procedure blanking period

Secondary Outcomes

  • Recurrence of any atrial arrhythmia lasting at least 30 seconds occurring after a 3-month blanking period or anti-arrhythmic drug use after a 3-months blanking period(up to 24 months with a minimum of 12 months follow up after a single ablation procedure.)
  • Procedure time(immediate after procedure)
  • Anti-arrhythmic drug use after a 3-month blanking period(up to 24 months with a minimum of 12 months follow up after a single ablation procedure.)
  • Number of patients with recurrence as atrial fibrillation(up to 24 months with a minimum of 12 months follow up after a single ablation procedure.)
  • Procedural complications(immediate after procedure)
  • Proportion of cardioversion performed among patients with the recurrence of atrial arrhythmia.(up to 24 months with a minimum of 12 months follow up after a single ablation procedure.)
  • Number of patients with recurrence as atrial tachycardia/flutter(up to 24 months with a minimum of 12 months follow up after a single ablation procedure.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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