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Status unknownNCT03682887Updated Sep 5, 2023

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

An interventional study of Cryoballoon PV isolation group and Cryoballoon PV isolation with Additional RA linear ablation group in Persistent Atrial Fibrillation, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
195
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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

Read the 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

  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.

B. Progress and rhythm/ECG follow-up

  1. To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
  2. Followed up for a minimum of 12 months after ablation.
  3. Outpatient clinic visits regularly at 1, 3, 6, and 12 months, and then every 6 months thereafter or upon the recurrence of symptoms after AFCA Rhythm control at 2 months, and thereafter every 6-month follow-up with
  4. ECG during every visit and 24-h Holter monitor recording at 3 and 6 months and every 6 months thereafter.
  5. If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.

C. Follow-up Patients were followed up for a minimum of 12 months after ablation. All the patients will be followed-up at 1, 3, 6, and 12 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.

9. Observation Items • Clinical Test Items and Observation Method A. Disease name, age, gender, weight, height, disease duration B. Evaluation of comorbid structural heart disease pattern C. Evaluation of clinically significant comorbid disease pattern D. Imaging quantitative assessment (All the examinations will be performed according to the need for treatment, regardless of the purpose of the study, and no additional imaging tests will be performed for study purposes.)

  1. Echocardiography: Ejection fraction, diastolic function index, atrial size, ventricular size, atrial volume
  2. 3D CT scan: Atrial size, ventricular size, atrial volume, and pericardial fat volume (This examination is indispensable for the safety of the procedure and for the use of 3D equipment in catheter ablation for atrial fibrillation in all clinical studies. The analysis of the atrial size, pericardial fat volume, etc. will be utilized for the purpose of risk assessment for recurrence-related factor detection and future recurrence risk. In other words, the purpose is to provide better treatment for patients at a higher level.) E. Hemodynamic quantitative evaluation: Measurement of atrial pressure before and after the procedure
02

Conditions studied

  • Persistent Atrial Fibrillation

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Keywords

  • Atrial fibrillation
  • Cryoballoon
  • Linear ablation
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 195 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Browse Yonsei University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
195 participants (actual)

Study arms

  • Active comparator
    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 -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

  • Experimental
    Cryoballoon PV isolation w/ RA linear ablation group

    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

  • ProcedureCryoballoon PV isolation group

    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.

  • ProcedureCryoballoon PV isolation with Additional RA linear ablation group

    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.

06

What researchers measure

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

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

Secondary outcomes

  1. Procedure time

    Time frame: immediate after procedure

  2. Anti-arrhythmic drug use after a 3-month blanking period

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

  3. 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

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

  4. Number of patients with recurrence as atrial fibrillation

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

  5. Number of patients with recurrence as atrial tachycardia/flutter

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

  6. Procedural complications

    Time frame: immediate after procedure

  7. Proportion of cardioversion performed among patients with the recurrence of atrial arrhythmia.

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

07

Study locations

1 site
  • Severance Cardiovascular Hospital, Yonsei University Health System
    Seoul, 03722, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2019 (actual). Primary completion is estimated for Sep 2025, 70 months after the start.

Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 70 months is above that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2018
First posted
Sep 25, 2018
StartActual
Nov 7, 2019
Primary completionEst.
Sep 2025
CompletionEst.
Sep 2025
Last update
Sep 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03682887
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 25, 2018
Start date
Nov 7, 2019
Primary completion
Sep 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Sep 5, 2023

Study contacts

Hui-Nam Pak
principal investigator · Yonsei University Health System, Severance Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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