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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in South Korea

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.

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 groups in NCT07034378
Study groupRoleWhat they receive
Extended cryoballoon ablationExperimentalThe 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 ablationActive comparatorApplication 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 ablationActive comparatorCARTO 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.

  1. 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)

  1. 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)

  2. 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

  3. Atrial fibrillation recurrence

    Atrial fibrillation recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications

    Measured: 1 year

  4. Incidence of peri-procedural complications

    including stroke, cardiac tamponade, esophageal injury, phrenic nerve damage, and death

    Measured: Periprocedural

  5. Rate of first-pass isolation or first-freeze isolation

    Measured: during procedure

  6. Procedure duration (minutes)

    Measured: during procedure

  7. Ablation time (minutes)

    Measured: during procedure

  8. Fluoroscopy time (minutes)

    Measured: during procedure

  9. LA dwelling time

    Measured: during procedure

  10. Ablation time (seconds)

    Measured: during procedure

  11. 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

  12. Number of repeat procedures

    Measured: 1 year

  13. AF burden by 2-week patch monitoring

    AF burden assessed at 12 months after ablation

    Measured: 1 year

  14. 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.

  1. First posted24 Jun 2025
  2. Study start28 Sep 2021
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2025

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT07034378.

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.

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