Clinical trial NCT03920891: Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)
Official title: Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Valvular Atrial Fibrillation
Keywords: Valvular Atrial fibrillation
Radiofrequency Pulmonary vein isolation
Cryoballoon Pulmonary Vein isolation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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: 154 (77 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 every 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 months for 2 years, and every year after 2 years 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.

Eligibility criteria: Inclusion Criteria:

* 1. Patient with hemodynamic corrected valvular atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
* 2. Left atrium size \< 50mm
* 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 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 non-valvular atrial fibrillation
* 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

Primary outcomes:
measure: Safety evaluation: Procedure-related cardiac complication rate
timeFrame: within 30 days post procedure
measure: Efficacy evaluation: clinical recurrence rate
timeFrame: Within 1 year after 3 months of procedure
Secondary outcomes:
measure: Comparison of procedure time
timeFrame: immediate after procedure
measure: Comparison of ablation time
timeFrame: immediate after procedure
measure: Comparison of hospitalization period
timeFrame: immediate after procedure
measure: Comparison of re-hospitalization rate after the procedure
timeFrame: immediate after procedure
measure: Comparison of re-hospitalization rate after the procedure
timeFrame: 12 months after procedure
measure: Comparison of number of electrical cardioversion after the procedure
timeFrame: immediate after procedure
measure: Comparison of number of electrical cardioversion after the procedure
timeFrame: 12 months after procedure
measure: Major cardiovascular event rate - death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
timeFrame: immediate after procedure and 12 months after procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References: