Clinical Trial Comparing the Cooling Effect of Different Balloon Sizes of Cryoballoon Ablation in Patients with Paroxysmal Atrial Fibrillatio

Not Applicable

Recruiting

• Conditions: paroxysmal atrial fibrillation; atrial fibrillation, catheter ablation, cryoballoon; D001281

• Registration Number: JPRN-jRCTs052230160
• Lead Sponsor: Miyamoto Koji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-09
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Patients aged 20-85 years old
2. Patients diagnosed with symptomatic paroxysmal atrial fibrillation and determined by the attending physician to require catheter ablation
3. Patients with written informed consent

Exclusion Criteria

1. Patients with history of catheter ablation and/or surgery of atrial fibrillation
2. Patients with left atrial dimension more than 55 mm
3. Pregnant or potentially pregnant patients
4. Patients with concomittant participation in intervention study with other medication and/or medical instrument
5. Patients with active systemic infection
6. Patients with atrial myxoma and/or thrombus in the heart
7. Patients with artificial heart valves (mechanical or bioprosthetic valves) or a MitraClip device implanted at the site where the catheter passes
8. Patients who have undergone ventricular or atrial surgery within the last 4 weeks before obtaining consent
9. Patients with pulmonary vein stents in place.
10. Patients with cryoglobulinemia
11. Patients determined that the insertion into the atrium or operations within the atrium cannot be safely performed
12. Patients with intra-atrial baffles, atrial septal defect patches, and/or other surgical interventions in the atrium or its vicinity
13. Patients with severe coagulation disorders or those who cannot tolerate anticoagulation therapy during electrophysiological procedures.
14. Patients for whom catheter manipulation within the cardiac chambers is considered unsafe, making invasive electrophysiological procedures contraindicated
15. Patients with inaccessible vascular access or occluded femoral veins
16. Severe renal impairment (estimated glomerular filtration rate <15 mL/min/1.73m2)
17. Patients who cannot undergo MRI
18. Patients for whom the principal investigator or co-investigator has determined that participation in the study is not appropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of cases without gaps (insufficient cooling areas) along the pulmonary vein isolation line on delayed contrast-enhanced cardiac MRI following Cryoballoon Ablation (CBA).