Status:
NOT_YET_RECRUITING
Rotor Modulation Ablation for the Treatment of Persistent Atrial Fibrillation
Lead Sponsor:
Zhujiang Hospital
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
21-81 years
Phase:
NA
Brief Summary
For Persistent atrial fibrillation (PeAF), the therapeutic effect of catheter ablation needs to be further improved. 3.Circumferential pulmonary vein isolation (CPVI) is the cornerstone of catheter ab...
Detailed Description
1. Atrial fibrillation (AF) is a common arrhythmia, and its incidence increases with age. In addition, AF is extremely harmful, and studies have found that AF significantly increases mortality, affect...
Eligibility Criteria
Inclusion
- 1\. Clinical Diagnosed of persistent atrial fibrillation； 2. Has an indication for radiofrequency ablation surgery and no contraindications to radiofrequency ablation (according to Current knowledge and management of atrial fibrillation: consensus of Chinese experts 2021)；3. Patients between the ages of 20 and 80 years, male or female；4. Left atrial systolic anteroposterior diameter (LAs)\<55mm measured by thoracic ultrasound； 5. Patients who agree to undergo clinical trials and comply with the protocols, voluntarily sign the informed consent form.
Exclusion
- 1\. History of previous radiofrequency ablation of atrial fibrillation; 2. Left ventricular ejection fraction (LVEF) \< 30% measured by thoracic ultrasound; 3. Cardiac surgery within the previous 180 days or expecting cardiac surgery within 180 days; 4. Coronary PTCA/stenting within the previous 90 days; 5. Patients with severe pulmonary, hepatic and renal insufficiency; 6. Diagnosed atrial myxoma; 7. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment; 8. Women who are pregnant or who plan to become pregnant during the study; 9. Acute illness or active infection at time of index procedure; 10. Acute coronary syndrome within the previous 60 days; 10. History of blood clotting or bleeding abnormalities; 12. Contraindication to anticoagulation; 13. Life expectancy less than 1 year; 14. Uncontrolled heart failure; 15. Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter introduction or positioning; 16. Cannot be removed from antiarrhythmic drugs for reasons other than atrial fibrillation; 17. Unwilling or unable to provide informed consent; 18. Uncontrolled alcoholics; 19. Patients with hypertrophic cardiomyopathy; 20. Patients with poorly controlled hypertension (blood pressure \>140/90 mmHg despite antihypertensive therapy).
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06539819
Start Date
September 1 2024
End Date
December 1 2026
Last Update
August 6 2024
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