The prospective randomized comparison study of the effect and safety of left atrial roof linear ablation utilizing the cryoballoon and the radiofrequency catheter ablation in multicenter

The prospective randomized comparison study of the effect and safety of left atrial roof linear ablation utilizing the cryoballoon and the radiofrequency catheter ablation in multicenter - The prospective randomized comparison study of the effect and safety of left atrial roof linear ablation utilizing the cryoballoon and the radiofrequency catheter ablation in multicenter

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000040339

Enrollment

100

Registered

2020-05-08

Start date

2019-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-valvular persistent atrial fibrillation

Interventions

Performing the ablation of left atrial roof linear ablation utilizing cryoballoon Performing the ablation of left atrial roof linear ablation utilizing radiofrequency catheter ablation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: the de-novo catheter ablation case with non-valvular atrial fibrillation with sustaining period less than 5 years

Exclusion criteria

Exclusion criteria: left atrial diameter more than 55mm persistent atrial fibrillation sustaining more than 5 years left ventricle ejection fraction less than 30% severe valvular disease reversible atrial fibrillation like hyperthyroidism intra-cardiac thrombosis frail patient NYHA 4 myocardial infarction or cardiac surgery within 3 months severe bleeding no durability for heparin or direct oral anticoagulant

Design outcomes

Primary

Measure	Time frame
1. the success rate and crossover rate of the each group	—

Secondary

Measure	Time frame
2. the ablation procedure duration, fluoroscopy dose and fluoroscopy duration required to make complete linear blockline in left atrial roof 3. the occurrence rate of cardiac tamponade, systemic embolism, pulmonary vein stenosis, phrenic nerve injury and gastric hypomotility	—

Countries

Japan

Contacts

Public ContactTatsuhiko Hirao

Japanese Red Cross Yokohama City Bay Hospital Department of Cardiology

tatsuhiko1984@gmail.com0456286100

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026