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Completed

NCT Number: NCT07034378

Comparison Between Extended Cryoablation, Standard Cryoablation, and Radiofrequency Ablation

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital, Seongnam-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Radiofrequency ablation

Procedure

Radiofrequency ablation of pulmonary veins

Extended cryoballoon ablation

Procedure

Cryoablation of pulmonary veins + posterior wall isolation

Standard cryoballoon ablation

Procedure

Standard cryoablation of pulmonary veins

Primary outcomes

  1. 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

Secondary outcomes

  1. Atrial arrhythmia recurrence during blanking period

    Time frame: during blanking period (3 months)

    Atrial arrhythmia recurrence during blanking period (3 months) after one or two procedures with/without antiarrhythmic medications

  2. Atrial tachycardia or flutter recurrence

    Time frame: 1 year

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

  3. Atrial fibrillation recurrence

    Time frame: 1 year

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

  4. Incidence of peri-procedural complications

    Time frame: Periprocedural

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

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

    Time frame: during procedure

  6. Procedure duration (minutes)

    Time frame: during procedure

  7. Ablation time (minutes)

    Time frame: during procedure

  8. Fluoroscopy time (minutes)

    Time frame: during procedure

  9. LA dwelling time

    Time frame: during procedure

  10. Ablation time (seconds)

    Time frame: during procedure

  11. Quality of life changes at 12 months compared to baseline

    Time frame: 1 year

    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

  12. Number of repeat procedures

    Time frame: 1 year

  13. AF burden by 2-week patch monitoring

    Time frame: 1 year

    AF burden assessed at 12 months after ablation

  14. LA pressure, mmHg (max/min/mean)

    Time frame: during procedure

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study 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

Acronym: EXCAPE-AF

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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