Cryoballoon pulmonary vein isolation vs. Radiofrequency pulmonary vein isolation with additional right atrial linear ablation for Valvular atrial fibrillation

Cryoballoon pulmonary vein isolation vs. Radiofrequency pulmonary vein isolation with additional right atrial linear ablation for Valvular atrial fibrillation: Prospective randomized trial (CRAVA Trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003825

Enrollment

154

Registered

2019-04-19

Start date

2019-09-02

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : 1. Prospective randomization (cryoballoon PV isolation group vs. Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation) (Using the Python program, a r

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

Eligibility

Sex/Gender

All

Inclusion 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 reccurrence 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

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

Design outcomes

Primary

Measure	Time frame
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;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	—

Measure

Time frame

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;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

—

Secondary

Measure	Time frame
Comparison of procedure time, ablation time, and hospitalization period;Comparison of re-hospitalization rate and number of electrical cardioversion after the procedure;Major cardiovascular event rate – death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure	—

Countries

Korea, Republic of

Contacts

Public ContactSohee Joo

Yonsei University Health System, Severance Hospital

shjoo95@yuhs.ac+82-2-2228-8528

Outcome results