Atrial Fibrillation, PersistentEXCAPE-AFNCT07034378
Comparison Between Extended Cryoablation, Standard Cryoablation, and Radiofrequency Ablation
A study testing Radiofrequency ablation, Extended cryoballoon ablation and Standard cryoballoon ablation in people with Atrial Fibrillation, Persistent, run by Asan Medical Center at 3 sites in South Korea.
Trial summary
The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- Radiofrequency ablation, Extended cryoballoon ablation and Standard cryoballoon ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 28 Sep 2021to 28 Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18-80 years
- Patients with persistent (≥7 days) AF documented on 12-lead ECG or Holter monitoring.
- AF refractory/intolerant to class I or III antiarrhythmic drugs
- Able and willing to provide written informed consent to CB or RF ablation and participation in this investigation
Who cannot join
- Age <18 years old or >80 years old
- Paroxysmal AF lasting <7 days
- Mitral stenosis or mechanical prosthetic valve
- Patients with left atrial size ≥ 50 mm (2D echocardiography, Anterior-posterior diameter in parasternal long axis view)
- Anatomy of pulmonary vein not suitable for standard CB or extended CB, including common ostium or ostium size > 26mm
- Pregnant woman of childbearing age with a positive pregnancy test before treatment
Show all 16Show fewer
- Presence of atrial septal defect or patent foramen ovale closure device
- Presence of intracardiac thrombus
- Contraindications to the systemic anticoagulation
- NYHA functional class IV heart failure
- Prior catheter or surgical ablation of AF
- Acute coronary syndrome within 3 months
- Planned open heart surgery within 3 months
- Prior open-heart surgery within 3 months
- End stage renal disease or chronic kidney disease (estimated glomerular filtration rate [MDRD method] < 30mL/min/1.73m²)
- Life expectancy less than 1 year.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul, 05505
Asan Medical Center
Seoul
About this study
Official title: Comparison of Extended Cryoballoon Ablation, Standard Cryoballoon Ablation, and Radiofrequency Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Clinical Trial
The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation
Read the detailed description
The posterior wall of the left atrium is known to contribute to arrhythmogenicity and has been associated with higher rates of atrial fibrillation (AF) recurrence. In this trial, we aim to evaluate whether extended cryoballoon ablation-comprising pulmonary vein isolation (PVI) plus posterior wall isolation-results in superior rhythm outcomes compared to standard cryoballoon ablation (PVI only) or radiofrequency ablation (PVI only). Patients will be randomly assigned to one of three treatment arms: extended cryoballoon ablation, standard cryoballoon ablation, or radiofrequency ablation. Each patient will receive the assigned treatment accordingly. The primary outcome is the incidence of atrial tachyarrhythmias-including atrial fibrillation, atrial flutter, and atrial tachycardia-lasting more than 30 seconds, occurring after discontinuation of antiarrhythmic drugs and following a 3-month post-procedure blanking period. Outcomes will be compared at 1 year after the procedure.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- Radiofrequency ablation, Extended cryoballoon ablation, Standard cryoballoon 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.
Radiofrequency ablationProcedure or surgery
Radiofrequency ablation of pulmonary veins
Extended cryoballoon ablationProcedure or surgery
Cryoablation of pulmonary veins + posterior wall isolation
Standard cryoballoon ablationProcedure or surgery
Standard cryoablation of pulmonary veins
| Study group | Role | What they receive |
|---|---|---|
| Extended cryoballoon ablation | Experimental | The method of ablation, size of balloon, freezing time, and booster freezing will be decided by the participating center's policy or physician's discretion. Ablation strategies described above are highly recommended for all participants.
Additional posterior wall isolation should be performed by single 120 to 180 second CB application delivered at each site. Maximal posterior wall debulking should be attempted, although complete isolation may not always be achievable, as we considered that a large scar created by the CB application would provide sufficient anti-arrhythmic effects in terms of suppressing AF. The number and duration of CB application should be recorded in the case report form. Successful posterior wall isolation should be determined by 3-dimensional electro-anatomical mapping or differential pacing. The method and achievement of posterior wall isolation should be recorded in the case report form. Receives: Procedure: Extended cryoballoon ablation |
| Standard cryoballoon ablation | Active comparator | Application of TTI + 2 minutes or 180 seconds single-freezing is recommended when time-to-isolation (TTI) <60 seconds. Additional 120 seconds of booster-freezing after TTI + 2 or 180 seconds initial freezing is recommended when TTI value >60 seconds, or PV potentials were not discernable in the Achieve multipolar catheter. If temperatures below -40°C cannot be achieved due to improper occlusion or TTI > 90 seconds, freezing should be discontinued and reposition of balloon is recommended. Segmental ablation is allowed when the proper occlusion of PV by balloon cannot be achieved. Continuous phrenic capture should be monitored during the procedure in the right PVs to avoid phrenic nerve injury. Stop ablation immediately if phrenic nerve damage is suspected. No further ablation would be performed if the phrenic nerve damage is suspected. Touch-up ablation using irrigated radiofrequency ablation catheter would be permitted with conventional mapping method. Receives: Procedure: Standard cryoballoon ablation |
| Radiofrequency ablation | Active comparator | CARTO system (Biosense-Webster, USA): Ablation index (AI) CLOSE protocol . Navistar Smart-touch surround-flow catheter; 25-40 watts of energy; 40 seconds time limit; 10-30 gram of contact force; 40 seconds time limit; targeting AI value of 550 in anterior wall and 400 in the posterior wall; interlesion distance ≤6mm; using automatic lesion annotation (Visitag™) - type 3 tagging, 3mm stability for 5 seconds, force >5g over 50% of time; target AI value could be reduced (450 in anterior wall and 350 in posterior wall) according to the participating center's policy.
Ensite NavX system (Abbott, USA) :
TactiCath™ Quartz ablation catheter; delivering 25-35 watts of energy; 40 seconds time limit; 10-30 gram of contact force; using automatic lesion annotation (Automark Module), target lesion index value of 5-5.5 in the posterior wall and 5.5-6 in the anterior wall. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rates of atrial tachyarrhythmias
Incidence of atrial tachyarrhythmias (including atrial fibrillation, flutter, or tachycardia) lasting >30 seconds after discontinuation of antiarrhythmic therapy, assessed following a 3-month blanking period
Measured: 3-month blanking period post-procedure
Secondary outcomes (14)
Atrial arrhythmia recurrence during blanking period
Atrial arrhythmia recurrence during blanking period (3 months) after one or two procedures with/without antiarrhythmic medications
Measured: during blanking period (3 months)
Atrial tachycardia or flutter recurrence
Atrial tachycardia or flutter recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications
Measured: 1 year
Atrial fibrillation recurrence
Atrial fibrillation recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications
Measured: 1 year
Incidence of peri-procedural complications
including stroke, cardiac tamponade, esophageal injury, phrenic nerve damage, and death
Measured: Periprocedural
Rate of first-pass isolation or first-freeze isolation
Measured: during procedure
Procedure duration (minutes)
Measured: during procedure
Ablation time (minutes)
Measured: during procedure
Fluoroscopy time (minutes)
Measured: during procedure
LA dwelling time
Measured: during procedure
Ablation time (seconds)
Measured: during procedure
Quality of life changes at 12 months compared to baseline
Scores from the SF-36 questionnaire will be compared between baseline and the 1-year follow-up period. Scores will be scaled from 0 to 100, with higher values indicating better quality of life
Measured: 1 year
Number of repeat procedures
Measured: 1 year
AF burden by 2-week patch monitoring
AF burden assessed at 12 months after ablation
Measured: 1 year
LA pressure, mmHg (max/min/mean)
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start28 Sep 2021
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gi-Byoung Nam, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034378
- Sponsor's protocol ID
- AMC2020-1896
- Acronym
- EXCAPE-AF
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Extended Cryoballoon Ablation, Standard Cryoballoon Ablation, and Radiofrequency Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07034378
- Acronym / sponsor ID
- EXCAPE-AF / AMC2020-1896
- Conditions
- Atrial Fibrillation, Persistent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 24 Jun 2025 (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.
The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation
Detailed description
The posterior wall of the left atrium is known to contribute to arrhythmogenicity and has been associated with higher rates of atrial fibrillation (AF) recurrence. In this trial, we aim to evaluate whether extended cryoballoon ablation-comprising pulmonary vein isolation (PVI) plus posterior wall isolation-results in superior rhythm outcomes compared to standard cryoballoon ablation (PVI only) or radiofrequency ablation (PVI only). Patients will be randomly assigned to one of three treatment arms: extended cryoballoon ablation, standard cryoballoon ablation, or radiofrequency ablation. Each patient will receive the assigned treatment accordingly. The primary outcome is the incidence of atrial tachyarrhythmias-including atrial fibrillation, atrial flutter, and atrial tachycardia-lasting more than 30 seconds, occurring after discontinuation of antiarrhythmic drugs and following a 3-month post-procedure blanking period. Outcomes will be compared at 1 year after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extended cryoballoon ablation | Experimental | Procedure: Extended cryoballoon ablationThe method of ablation, size of balloon, freezing time, and booster freezing will be decided by the participating center's policy or physician's discretion. Ablation strategies described above are highly recommended for all participants. Additional posterior wall isolation should be performed by single 120 to 180 second CB application delivered at each site. Maximal posterior wall debulking should be attempted, although complete isolation may not always be achievable, as we considered that a large scar created by the CB application would provide sufficient anti-arrhythmic effects in terms of suppressing AF. The number and duration of CB application should be recorded in the case report form. Successful posterior wall isolation should be determined by 3-dimensional electro-anatomical mapping or differential pacing. The method and achievement of posterior wall isolation should be recorded in the case report form. |
| Standard cryoballoon ablation | Active comparator | Procedure: Standard cryoballoon ablationApplication of TTI + 2 minutes or 180 seconds single-freezing is recommended when time-to-isolation (TTI) <60 seconds. Additional 120 seconds of booster-freezing after TTI + 2 or 180 seconds initial freezing is recommended when TTI value >60 seconds, or PV potentials were not discernable in the Achieve multipolar catheter. If temperatures below -40°C cannot be achieved due to improper occlusion or TTI > 90 seconds, freezing should be discontinued and reposition of balloon is recommended. Segmental ablation is allowed when the proper occlusion of PV by balloon cannot be achieved. Continuous phrenic capture should be monitored during the procedure in the right PVs to avoid phrenic nerve injury. Stop ablation immediately if phrenic nerve damage is suspected. No further ablation would be performed if the phrenic nerve damage is suspected. Touch-up ablation using irrigated radiofrequency ablation catheter would be permitted with conventional mapping method. |
| Radiofrequency ablation | Active comparator | Procedure: Radiofrequency ablationCARTO system (Biosense-Webster, USA): Ablation index (AI) CLOSE protocol . Navistar Smart-touch surround-flow catheter; 25-40 watts of energy; 40 seconds time limit; 10-30 gram of contact force; 40 seconds time limit; targeting AI value of 550 in anterior wall and 400 in the posterior wall; interlesion distance ≤6mm; using automatic lesion annotation (Visitag™) - type 3 tagging, 3mm stability for 5 seconds, force >5g over 50% of time; target AI value could be reduced (450 in anterior wall and 350 in posterior wall) according to the participating center's policy. Ensite NavX system (Abbott, USA) : TactiCath™ Quartz ablation catheter; delivering 25-35 watts of energy; 40 seconds time limit; 10-30 gram of contact force; using automatic lesion annotation (Automark Module), target lesion index value of 5-5.5 in the posterior wall and 5.5-6 in the anterior wall. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18-80 years
- Patients with persistent (≥7 days) AF documented on 12-lead ECG or Holter monitoring.
- AF refractory/intolerant to class I or III antiarrhythmic drugs
- Able and willing to provide written informed consent to CB or RF ablation and participation in this investigation
Key exclusion criteria (16 listed)
- Age <18 years old or >80 years old
- Paroxysmal AF lasting <7 days
- Mitral stenosis or mechanical prosthetic valve
- Patients with left atrial size ≥ 50 mm (2D echocardiography, Anterior-posterior diameter in parasternal long axis view)
- Anatomy of pulmonary vein not suitable for standard CB or extended CB, including common ostium or ostium size > 26mm
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 |
|---|---|---|
| Radiofrequency ablationRadiofrequency ablation of pulmonary veins | Procedure or surgery | Radiofrequency ablation |
| Extended cryoballoon ablationCryoablation of pulmonary veins + posterior wall isolation | Procedure or surgery | Extended cryoballoon ablation |
| Standard cryoballoon ablationStandard cryoablation of pulmonary veins | Procedure or surgery | Standard cryoballoon ablation |
Primary outcome
the incidence rates of atrial tachyarrhythmias
Time frame: 3-month blanking period post-procedure
Incidence of atrial tachyarrhythmias (including atrial fibrillation, flutter, or tachycardia) lasting >30 seconds after discontinuation of antiarrhythmic therapy, assessed following a 3-month blanking period
14 secondary outcomes
Atrial arrhythmia recurrence during blanking period
Time frame: during blanking period (3 months)
Atrial tachycardia or flutter recurrence
Time frame: 1 year
Atrial fibrillation recurrence
Time frame: 1 year
Incidence of peri-procedural complications
Time frame: Periprocedural
Rate of first-pass isolation or first-freeze isolation
Time frame: during procedure
Procedure duration (minutes)
Time frame: during procedure
Ablation time (minutes)
Time frame: during procedure
Fluoroscopy time (minutes)
Time frame: during procedure
LA dwelling time
Time frame: during procedure
Ablation time (seconds)
Time frame: during procedure
Quality of life changes at 12 months compared to baseline
Time frame: 1 year
Number of repeat procedures
Time frame: 1 year
AF burden by 2-week patch monitoring
Time frame: 1 year
LA pressure, mmHg (max/min/mean)
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation, Extended cryoballoon ablation and Standard cryoballoon ablation in people with Atrial Fibrillation, Persistent, run by Asan Medical Center at 3 sites 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 16 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: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the incidence rates of atrial tachyarrhythmias (time frame: 3-month blanking period post-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 24 Jun 2025.