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

JRCT ID: jRCTs052230160

Registered date:09/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: paroxysmal atrial fibrillation
• Date of first enrollment: 24/01/2024
• Target sample size: 240
• Study type: Interventional

Intervention(s)

31 mm-CBA Group
Cryoballoon ablation (CBA) is performed using a 31 mm balloon size for paroxysmal atrial fibrillation.
28 mm-CBA Group
Cryoballoon ablation (CBA) is performed using a 28 mm balloon size for paroxysmal atrial fibrillation.

Outcome(s)

• Primary Outcome: 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).

Secondary Outcome

(Effectiveness)
1. The percentage of pulmonary veins without gaps (insufficient cooling areas) along the pulmonary vein isolation line on delayed contrast-enhanced cardiac MRI.
2. The area, length, and volume of the pulmonary vein isolation line on delayed contrast-enhanced cardiac MRI.
3. The percentage and severity of cases with esophageal injury observed on delayed contrast-enhanced cardiac MRI.
4. Pulmonary vein isolation success rate, total procedure time, left atrial procedure time, fluoroscopy time, radiation exposure, esophageal temperature reduction.
5. One-year recurrence rate of atrial fibrillation.
6. Percentage of cases with changes in balloon size, reasons for the changes, and success rates after the changes.
7. Changes and change rates in CK, CKMB, and Troponin T levels the day after CBA.
8. Changes and change rates in BNP levels, Cr, CCr, and eGFR one year after CBA.
9. Changes and change rates in left ventricular ejection fraction, left atrial diameter, left atrial volume, and left atrial volume index one year after CBA.
10. Incidence rates of cardiovascular events, all-cause mortality, and cardiovascular-related mortality one year after CBA.
(Safety)
1. Complications associated with CBA.
2. Adverse events related to the procedure.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Miyamoto Koji
• Source(s) of Monetary Support: Boston Scientific ISR