Persistent Atrial FibrillationNCT03682887
Cryoballoon Pulmonary Vein Isolation vs. Cryoballoon Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Persistent Atrial Fibrillation (CRARAL Trial)
A study testing Cryoballoon PV isolation group and Cryoballoon PV isolation with Additional RA linear ablation group in people with Persistent Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Cryoballoon PV isolation group and Cryoballoon PV isolation with Additional RA linear ablation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2019to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 03722
About this study
Official title: Cryoballoon Pulmonary Vein Isolation vs. Cryoballoon Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Persistent Atrial Fibrillation: Prospective Randomized Trial (CRARAL Trial)
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
- Study design
- 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.)
- Target number of subjects: 278 (138 per group)
- 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.
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
Cryoballoon PV isolation group
- Pulmonary vein isolation will be performed using a cryoballoon catheter.
- Esophageal temperature will be monitored to prevent esophageal injury.
- A 28mm cryoballoon catheter will be used.
- Cryoablation will be performed for 180 secs at -30ºC or below on condition that the pulmonary vein is occluded with a cryoballoon.
- CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
- The procedure and ablation times will be evaluated.
- The procedure will be completed without checking any other trigger came from beyond pulmonary vein after the administration of isoproterenol
- 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
- Pulmonary vein isolation will be performed using a cryoballoon catheter as the same as cryoballoon PV isolation group.
- Additional cavo-tricuspid isthmus ablation will be performed with a radiofrequency catheter.
- Additional SVC-right atrial septal linear ablation will be performed with a radiofrequency catheter.
- If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local RF ablation will be followed.
- The procedure and ablation times will be evaluated.
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Followed up for a minimum of 12 months after ablation.
- 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
- ECG during every visit and 24-h Holter monitor recording at 3 and 6 months and every 6 months thereafter.
- 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.
- 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.
- 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.)
- Echocardiography: Ejection fraction, diastolic function index, atrial size, ventricular size, atrial volume
- 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
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Cryoballoon PV isolation group, Cryoballoon PV isolation with Additional RA linear ablation group
- Keywords
- Atrial fibrillation, Cryoballoon, Linear ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon PV isolation groupProcedure or surgery
- 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.)
- Target number of subjects: 278 (138 per group)
- 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.
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
Cryoballoon PV isolation with Additional RA linear ablation groupProcedure or surgery
- 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.)
- Target number of subjects: 278 (138 per group)
- 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.
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Cryoballoon PV isolation with Additional RA linear ablation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months with a minimum of 12 months follow up after a single ablation procedure.
Secondary outcomes (7)
Procedure time
Measured: immediate after procedure
Anti-arrhythmic drug use after a 3-month blanking period
Measured: 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
Measured: 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
Measured: 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
Measured: up to 24 months with a minimum of 12 months follow up after a single ablation procedure.
Procedural complications
Measured: immediate after procedure
Proportion of cardioversion performed among patients with the recurrence of atrial arrhythmia.
Measured: up to 24 months with a minimum of 12 months follow up after a single ablation procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start7 Nov 2019
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Nam Pak, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682887
- Sponsor's protocol ID
- 4-2018-0734
- Status last verified
- Aug 2023
- First submitted
- 21 Sep 2018
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Pulmonary Vein Isolation vs. Cryoballoon Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Persistent Atrial Fibrillation: Prospective Randomized Trial (CRARAL Trial)
- ClinicalTrials.gov ID
- NCT03682887
- Acronym / sponsor ID
- 4-2018-0734
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial fibrillation, Cryoballoon, Linear ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Study design
- 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.)
- Target number of subjects: 278 (138 per group)
- 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.
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
Cryoballoon PV isolation group
- Pulmonary vein isolation will be performed using a cryoballoon catheter.
- Esophageal temperature will be monitored to prevent esophageal injury.
- A 28mm cryoballoon catheter will be used.
- Cryoablation will be performed for 180 secs at -30ºC or below on condition that the pulmonary vein is occluded with a cryoballoon.
- CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
- The procedure and ablation times will be evaluated.
- The procedure will be completed without checking any other trigger came from beyond pulmonary vein after the administration of isoproterenol
- 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
- Pulmonary vein isolation will be performed using a cryoballoon catheter as the same as cryoballoon PV isolation group.
- Additional cavo-tricuspid isthmus ablation will be performed with a radiofrequency catheter.
- Additional SVC-right atrial septal linear ablation will be performed with a radiofrequency catheter.
- If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local RF ablation will be followed.
- The procedure and ablation times will be evaluated.
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Followed up for a minimum of 12 months after ablation.
- 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
- ECG during every visit and 24-h Holter monitor recording at 3 and 6 months and every 6 months thereafter.
- 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.
- 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.
- 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.)
- Echocardiography: Ejection fraction, diastolic function index, atrial size, ventricular size, atrial volume
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon PV isolation group | Active comparator | Procedure: Cryoballoon PV isolation group1. 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. |
| Cryoballoon PV isolation w/ RA linear ablation group | Experimental | Procedure: Cryoballoon PV isolation with Additional RA linear ablation group1. 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoballoon PV isolation group1. 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. | Procedure or surgery | Cryoballoon PV isolation group |
| Cryoballoon PV isolation with Additional RA linear ablation group1. 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. | Procedure or surgery | Cryoballoon PV isolation w/ RA linear ablation group |
Primary outcome
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
7 secondary outcomes
Procedure time
Time frame: immediate after procedure
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.
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.
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.
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.
Procedural complications
Time frame: immediate after procedure
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Nam Pak principal investigator
Yonsei University Health System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon PV isolation group and Cryoballoon PV isolation with Additional RA linear ablation group in people with Persistent Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of any atrial arrhythmia (time frame: up to 24 months with a minimum of 12 months follow up after a single ablation procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.