Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03920917
Study type Interventional
Source Yonsei University
Contact Hui-Nam Pak, M.D, Ph.D.
Phone 82-2-2228-8459
Email hnpak@yuhs.ac
Status Recruiting
Phase N/A
Start date April 3, 2019
Completion date March 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Recruiting NCT06014996 - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation. N/A
Completed NCT03624881 - Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU) Phase 4
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Recruiting NCT05905835 - Treatment of PAF With the Synaptic System N/A
Active, not recruiting NCT05534581 - Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients With Symptomatic Paroxysmal Atrial Fibrillation Phase 4
Active, not recruiting NCT05618340 - PFA for Paroxysmal Atrial Fibrillation N/A
Not yet recruiting NCT05974098 - Quality of Life Influencing Factors
Not yet recruiting NCT05024630 - Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension N/A
Completed NCT01913522 - Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration N/A
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Terminated NCT01925885 - Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF) N/A
Withdrawn NCT01917981 - Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation Phase 3
Completed NCT01693107 - Atrial Fibrillation Force Contact Ablation Study
Completed NCT01842529 - Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery Phase 2
Completed NCT00971204 - Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation Phase 2
Completed NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System N/A
Recruiting NCT05172765 - Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF) N/A
Recruiting NCT04529785 - Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation N/A
Completed NCT04022954 - HD Mapping of Atrial Fibrillation in Asia Pacific