Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
A. Study design
B. Progress and rhythm/ECG follow-up
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoballoon Pulmonary Vein isolation | Experimental |
|
|
| Radiofrequency Pulmonary Vein isolation | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoballoon Pulmonary Vein isolation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation: Procedure-related cardiac complication rate | including open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications within 30 days post procedure | within 30 days post procedure |
| Efficacy evaluation: clinical recurrence rate | Defined as atrial fibrillation or atrial tachycardia > 30 sec after 3 months within 1 year; based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 3 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms | Within 1 year after 3 months of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of procedure time | immediate after procedure | |
| Comparison of ablation time | immediate after procedure | |
| Comparison of hospitalization period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Nam Pak, M.D, Ph.D. | Contact | 82-2-2228-8459 | hnpak@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Hui-Nam Pak, M.D, Ph.D. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Cardiovascular Hospital, Yonsei University Health System | Recruiting | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34465132 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation | Procedure |
|
|
| immediate after procedure |
| Comparison of re-hospitalization rate after the procedure | immediate after procedure |
| Comparison of re-hospitalization rate after the procedure | 12 months after procedure |
| Comparison of number of electrical cardioversion after the procedure | immediate after procedure |
| Comparison of number of electrical cardioversion after the procedure | 12 months after procedure |
| Major cardiovascular event rate - death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure | immediate after procedure and 12 months after procedure |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided