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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)

NCT03920891

Valvular Atrial Fibrillation

NOT_YET_RECRUITING NA

Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation

NCT05940597

Atrial Fibrillation Paroxysmal

ACTIVE_NOT_RECRUITING NA

Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF

NCT06199180

Atrial Fibrillation Recurrent

RECRUITING NA

Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF

NCT05296824

Paroxysmal Atrial Fibrillation

COMPLETED

Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)

NCT03912324

Paroxysmal Atrial Fibrillation

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Paroxysmal Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cryoballoon Pulmonary Vein isolation

1. Pulmonary vein isolation will be performed using a cryoballoon catheter.
2. Esophageal temperature will be monitored to prevent esophageal injury.
3. A 28mm second or third cryoballoon catheter will be used.
4. Esophageal temperature will be monitored to prevent esophageal injury.
5. Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon.
6. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
7. The procedure and cryoablation times will be evaluated.
8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Group Type EXPERIMENTAL

Cryoballoon Pulmonary Vein isolation

Intervention Type PROCEDURE

1. Pulmonary vein isolation will be performed using a cryoballoon catheter.
2. Esophageal temperature will be monitored to prevent esophageal injury.
3. A 28mm second or third cryoballoon catheter will be used.
4. Esophageal temperature will be monitored to prevent esophageal injury.
5. Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon.
6. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
7. The procedure and cryoablation times will be evaluated.
8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Radiofrequency Pulmonary Vein isolation

1. Pulmonary vein isolation will be performed using a radiofrequency catheter.
2. Additional cavo-tricuspid isthmus ablation will be performed with a radiofrequency catheter.
3. Additional superior vena cava-right atrial septal linear ablation will be performed with a radiofrequency catheter.
4. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed.
5. Evaluated the procedure and radiofrequency ablation time.
6. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Group Type ACTIVE_COMPARATOR

Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation

Intervention Type PROCEDURE

1. Pulmonary vein isolation will be performed using a radiofrequency catheter.
2. Additional cavo-tricuspid isthmus ablation will be performed with a radiofrequency catheter.
3. Additional superior vena cava-right atrial septal linear ablation will be performed with a radiofrequency catheter.
4. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed.
5. Evaluated the procedure and radiofrequency ablation time.
6. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cryoballoon Pulmonary Vein isolation

1. Pulmonary vein isolation will be performed using a cryoballoon catheter.
2. Esophageal temperature will be monitored to prevent esophageal injury.
3. A 28mm second or third cryoballoon catheter will be used.
4. Esophageal temperature will be monitored to prevent esophageal injury.
5. Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon.
6. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
7. The procedure and cryoablation times will be evaluated.
8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Intervention Type PROCEDURE

Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation

1. Pulmonary vein isolation will be performed using a radiofrequency catheter.
2. Additional cavo-tricuspid isthmus ablation will be performed with a radiofrequency catheter.
3. Additional superior vena cava-right atrial septal linear ablation will be performed with a radiofrequency catheter.
4. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed.
5. Evaluated the procedure and radiofrequency ablation time.
6. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No