Comparison Between Extended Cryoablation, Standard Cryoablation, and Radiofrequency Ablation

NCT07034378 | Completed

• 1 other identifier: AMC2020-1896
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Atrial Fibrillation, Persistent

Outcome Measures

Primary Outcomes (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

  3-month blanking period post-procedure

Secondary Outcomes (14)

• Atrial arrhythmia recurrence during blanking period

  during blanking period (3 months)

• Atrial tachycardia or flutter recurrence

  1 year

• Atrial fibrillation recurrence

  1 year

• Incidence of peri-procedural complications

  Periprocedural

• Rate of first-pass isolation or first-freeze isolation

  during procedure

Study Arms (3)

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.

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.

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.

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

Radiofrequency ablation of pulmonary veins

Radiofrequency ablation

Extended cryoballoon ablation PROCEDURE

Cryoablation of pulmonary veins + posterior wall isolation

Extended cryoballoon ablation

Standard cryoballoon ablation PROCEDURE

Standard cryoablation of pulmonary veins

Standard cryoballoon ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 24, 2025
• Study Start: September 28, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)