NCT07034378Completed
Comparison Between Extended Cryoablation, Standard Cryoablation, and Radiofrequency Ablation
Comparison of Extended Cryoballoon Ablation, Standard Cryoballoon Ablation, and Radiofrequency Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 24 Jun 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 288 (actual)
- First submitted
- 12 May 2025
- Start date
- Sept 2021
- Primary completion date
- Feb 2025
- Lead sponsor
- Asan Medical Center
- Diseases
- Atrial fibrillation
- NCT number
- NCT07034378
What you commit to
- Study type: Interventional
- Participants enrolled: 288
- From Sept 2021 to the primary completion date, Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior catheter or surgical ablation of AF
- Prior open-heart surgery within 3 months
Other illness
- NYHA functional class IV heart failure
- Acute coronary syndrome within 3 months
- Planned open heart surgery within 3 months
- End stage renal disease or chronic kidney disease (estimated glomerular filtration rate \[MDRD method\] \< 30mL/min/1.73m²)
Age
- Age \<18 years old or \>80 years old
- Pregnant woman of childbearing age with a positive pregnancy test before treatment
Other
- 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
- Presence of atrial septal defect or patent foramen ovale closure device
- Presence of intracardiac thrombus
- Contraindications to the systemic anticoagulation
- Life expectancy less than 1 year.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.