Condition or disease | Intervention/treatment | Phase |
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Paroxysmal Atrial Fibrillation | Procedure: Cryoballoon Pulmonary Vein isolation Procedure: Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | April 3, 2019 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | March 2024 |
Arm | Intervention/treatment |
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Experimental: Cryoballoon Pulmonary Vein isolation
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Procedure: Cryoballoon Pulmonary Vein isolation
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Active Comparator: Radiofrequency Pulmonary Vein isolation
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Procedure: Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation
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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hui-Nam Pak, M.D, Ph.D. | 82-2-2228-8459 | hnpak@yuhs.ac |
Korea, Republic of | |
Severance Cardiovascular Hospital, Yonsei University Health System | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Contact: Hui-Nam Pak, M.D., Ph.D. 82-2-2228-8459 hnpak@yuhs.ac |
Principal Investigator: | Hui-Nam Pak, M.D, Ph.D. | Severance Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | April 14, 2019 | ||||
First Posted Date ICMJE | April 19, 2019 | ||||
Last Update Posted Date | January 5, 2021 | ||||
Actual Study Start Date ICMJE | April 3, 2019 | ||||
Estimated Primary Completion Date | March 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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 ICMJE | Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Paroxysmal Atrial Fibrillation: Prospective Randomized Trial (CRAPAF Trial) | ||||
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
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Paroxysmal Atrial Fibrillation | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
330 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 2024 | ||||
Estimated Primary Completion Date | March 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03920917 | ||||
Other Study ID Numbers ICMJE | 4-2019-0139 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Yonsei University | ||||
Study Sponsor ICMJE | Yonsei University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Yonsei University | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |