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 | Not Yet Recruiting DMC

• 1 other identifier: 4-2019-0141
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. We previously reported that the rhythm outcome of radiofrequency (RF) catheter ablations are equivalent in patients with non-valvular atrial fibrillation and in those with surgically and hemodynamically corrected valvular atrial fibrillation. In contrast, the Cryoballoon ablation can reduce the procedure times, it cannot conduct empirical linear ablation or extra-pulmonary vein foci ablation. The aim of this study is to compare Cryoballoon pulmonary vein isolation and RF ablation including linear ablation or extra-pulmonary vein foci ablations in patients with hemodynamically corrected valvular atrial fibrillation.

Conditions

Valvular Atrial Fibrillation

Keywords

Valvular Atrial fibrillation; Radiofrequency Pulmonary vein isolation; Cryoballoon Pulmonary Vein isolation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Comparison of procedure time

  immediate after procedure

• Comparison of ablation time

  immediate after procedure

• Comparison of hospitalization period

  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

Study Arms (2)

Cryoballoon Pulmonary Vein isolation

EXPERIMENTAL

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.

Procedure: Cryoballoon Pulmonary Vein isolation

Radiofrequency Pulmonary Vein isolation

ACTIVE COMPARATOR

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

Procedure: Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation

Interventions

Cryoballoon Pulmonary Vein isolation 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.

Cryoballoon Pulmonary Vein isolation

Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation PROCEDURE

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

Radiofrequency Pulmonary Vein isolation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patient with hemodynamic corrected valvular atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
• \. Left atrium size \< 50mm
• \. paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
• \. Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)

You may not qualify if:

• \. Patients with permanent atrial fibrillation
• \. Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
• \. Patients with severe renal impairment or CT imaging difficulty using contrast media
• \. Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
• \. Patients with active internal bleeding
• \. Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
• \. Patients with non-valvular atrial fibrillation
• \. Patients with a severe comorbid disease
• \. Expected survival \< 1 year
• \. Drug addicts or alcoholics
• \. Patients who cannot read the consent form (illiterates, foreigners, etc.)
• \. Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 19, 2019
• Study Start: May 1, 2019
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

KR (1)