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

NCT03682887 | Unknown DMC

• 1 other identifier: 4-2018-0734
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillation; Cryoballoon; Linear ablation

Outcome Measures

Primary Outcomes (1)

• Recurrence of any atrial arrhythmia

  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

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

Secondary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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.

Procedure: Cryoballoon PV isolation group

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.

Procedure: Cryoballoon PV isolation with Additional RA linear ablation group

Interventions

Cryoballoon PV isolation group PROCEDURE

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

Cryoballoon PV isolation with Additional RA linear ablation group PROCEDURE

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 w/ RA linear ablation group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Nam Pak

  Yonsei University Health system, Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sample Size Determination A. 276 subjects will be enrolled in this study. After enrollment, subjects will be randomized in a 1:1 fashion to Cryoballoon PV isolation group (138 subjects) or Cryoballoon PV isolation group with additional RA linear ablation group (138 subjects). B. The difference in the recurrence of atrial fibrillation between the two groups will be identified based on the data, with 80% statistical power and a 5% two-sided alpha error rate, to examine the 16% estimated difference between the groups, considering an about 5% dropout rate. The clinical recurrence rate of atrial fibrillation in the general control group was set at 39.3% considering the existing literature and the data of this hospital. C. Statistical hypothesis: There is a significant difference in the clinical recurrence and risk of complications after cryoballoon pulmonary vein isolation and additional right atrial linear ablation for persistent atrial fibrillation.

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: November 7, 2019
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)