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Cryoballoon Pulmonary Vein Isolation vs. Cryoballoon Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Persistent Atrial Fibrillation (CRARAL Trial)

NCT03682887 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2023-09-05

No results posted yet for this study

Summary

Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation. However, it is not certain that cryoablation is effective and safe in patients with persistent atrial fibrillation, because of higher chance of recurrence compared to paroxysmal atrial fibrillation. The aim of this study is to evaluate the efficacy and safety of cryoballoon pulmonary vein isolation vs. cryoballoon pulmonary vein isolation with additional right atrial linear ablation for paroxysmal atrial fibrillation in a prospective randomized trial

Conditions

  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

Cryoballoon PV isolation group

1. Prospective randomization (cryoballoon PV isolation group vs. cryoballoon PV isolation group with additional RA linear ablation group) (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: 278 (138 per group) 3. Rhythm FU : ECG during every visit (1, 3, 6, and 12 months, and then every 6 months thereafter or upon the recurrence of symptoms after AFCA) and 24-h Holter monitor recording at 3 and 6 months and every 6 months thereafter. 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.

PROCEDURE

Cryoballoon PV isolation with Additional RA linear ablation group

1. Prospective randomization (cryoballoon PV isolation group vs. cryoballoon PV isolation group with additional RA linear ablation group) (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: 278 (138 per group) 3. Rhythm FU : ECG during every visit (1, 3, 6, and 12 months, and then every 6 months thereafter or upon the recurrence of symptoms after AFCA) and 24-h Holter monitor recording at 3 and 6 months and every 6 months thereafter. 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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Hui-Nam Pak · Yonsei University Health system, Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682887 on ClinicalTrials.gov