Clinical trial NCT03920917: Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Paroxysmal Atrial Fibrillation: Prospective Randomized Trial (CRAPAF Trial)
Official title: Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Paroxysmal Atrial Fibrillation: Prospective Randomized Trial (CRAPAF Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial fibrillation
Radiofrequency Pulmonary vein isolation
Cryoballoon Pulmonary Vein isolation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 330
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation, and it can reduce the procedure time compared to conventional radiofrequency (RF) catheter ablation. Recently, high-power short-duration RF ablation has been known to reduce procedure time remarkably, and it can eliminate extra-pulmonary vein foci, which cannot be treated by Cryoballoon ablation. The aim of this study is to compare Cryoballoon ablation and high-power short-duration RF ablation in patients with paroxysmal atrial fibrillation in terms of the efficacy and the safety in a prospective randomized trial.

Detailed description: A. Study design

1. Prospective randomization (cryoballoon PV isolation group vs. Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation) (Using the Python program, a random number module is imported with the import random syntax, and the random number table for the two groups is created.)
2. Target number of subjects: 330 (165 per group)
3. Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 3,6 month, and thereafter every 6 months to 24 month, then 1 year; ECG if the patient has any symptom)
4. Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
5. All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.

B. Progress and rhythm/ECG follow-up

1. To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
2. Follow-up at 1 weeks, 3,6 months, and thereafter every 6-month after procedure.
3. Rhythm control at 3,6 months, and thereafter every 6-month follow-up with Holter
4. If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.

C. Follow-up All the patients will be followed-up at 1 weeks, 3, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed 3, 6 months, and thereafter every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.

Eligibility criteria: Inclusion Criteria:

* 1. Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
* 2. Left atrium size \< 45mm
* 3. paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
* 4. Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)

Exclusion Criteria:

* 1. Patients with persistent or permanent atrial fibrillation
* 2. Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
* 3. Patients with severe renal impairment or CT imaging difficulty using contrast media
* 4. Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
* 5. Patients with active internal bleeding
* 6. Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
* 7. Patients with valvular atrial fibrillation (mitral stenosis \>grade 2, mechanical valve, mitral valvuloplasty)
* 8. Patients with a severe comorbid disease
* 9. Expected survival \< 1 year
* 10. Drug addicts or alcoholics
* 11. Patients who cannot read the consent form (illiterates, foreigners, etc.)
* 12. Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study

Primary outcomes:
measure: Safety evaluation: Procedure-related cardiac complication rate
timeFrame: within 30 days post procedure
measure: Efficacy evaluation: clinical recurrence rate
timeFrame: Within 1 year after 3 months of procedure
Secondary outcomes:
measure: Comparison of procedure time
timeFrame: immediate after procedure
measure: Comparison of ablation time
timeFrame: immediate after procedure
measure: Comparison of hospitalization period
timeFrame: immediate after procedure
measure: Comparison of re-hospitalization rate after the procedure
timeFrame: immediate after procedure
measure: Comparison of re-hospitalization rate after the procedure
timeFrame: 12 months after procedure
measure: Comparison of number of electrical cardioversion after the procedure
timeFrame: immediate after procedure
measure: Comparison of number of electrical cardioversion after the procedure
timeFrame: 12 months after procedure
measure: Major cardiovascular event rate - death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
timeFrame: immediate after procedure and 12 months after procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
affiliation: Severance Hospital
name: Hui-Nam Pak, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pak HN, Park JW, Yang SY, Kim TH, Uhm JS, Joung B, Lee MH, Yu HT. Cryoballoon Versus High-Power, Short-Duration Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Single-Center, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2021 Sep;14(9):e010040. doi: 10.1161/CIRCEP.121.010040. Epub 2021 Sep 1.