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

Launched by YONSEI UNIVERSITY · Apr 16, 2019

Keywords

ClinConnect Summary

The CRAVA Trial is a clinical study that aims to compare two different methods of treating a heart condition called valvular atrial fibrillation, which is an irregular heartbeat that can occur alongside heart valve problems. The two methods being studied are Cryoballoon ablation and Radiofrequency (RF) ablation. Cryoballoon ablation involves cooling areas of the heart to block abnormal electrical signals, while RF ablation uses heat to achieve the same goal. This trial will help determine which method is more effective and safer for patients who have had surgery to correct their heart valves and still experience this irregular heartbeat.

To be eligible for this trial, participants must be between 20 and 80 years old, have a specific type of atrial fibrillation that comes back even with medication, and have a heart size that meets certain criteria. They also need to be on blood-thinning medication to prevent strokes. However, certain patients, including those with permanent atrial fibrillation or severe heart issues, will not be eligible. If you participate, you can expect to undergo one of these two procedures and be monitored closely for results. It's important to understand the potential benefits and risks of each method, and you'll have the opportunity to ask questions before deciding to join.

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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