Atrial Fibrillation
Conditions
Brief summary
The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.
Interventions
PROCEDURESTABLE-SR
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm
PROCEDURESTABLE-AF
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation
PROCEDURECPVI
ablate around the pulmonary vein orifice
Sponsors
Yantai Yuhuangding Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients age is 18-80 years; 2. Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \> 7 days; 3. Patients can sign the written informed consent for the study; 4. Patients can endure the required follow-up.
Exclusion criteria
1. Patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation 2. Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter 3. Left atrial diameter \>55mm 4. Left ventricular ejection fraction \<35% 5. Left atrial thrombus 6. Postoperative cardiac surgery 7. After valve replacement 8. After permanent pacemaker implantation 9. hypertrophic cardiomyopathy 10. Patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease 11. Hemorrhagic stroke within 6 months 12. Transient ischemic attack or ischemic stroke within 1 month 13. Mental disorder or history of mental illness and inability to cooperate voluntarily 14. Breastfeeding, pregnancy and women planning or likely to become pregnant 15. Life expectancy \<12 months 16. Participating in other interventional clinical trials 17. The researchers judged that it was not suitable for inclusion in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of no atrial arrhythmias greater than 30 seconds | at least 18 months follow up | The incidence of no atrial arrhythmias greater than 30 seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds | at least 18 months follow up | No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds |
| Atrial fibrillation load | at least 18 months follow up | Atrial fibrillation load |
| No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds | at least 18 months follow up | No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds |
| Ablation time | 1 week after patient enrollment | the total Ablation time, during CPVI and after CPVI |
| Incidence of peri-procedural complications | at least 18 months follow up | stroke, PV stenosis, cardiac perforation, esophageal injury and death |
| Procedure time | Surgical procedure | time that the patient spend in the procedure room |
Contacts
Primary ContactHongxia Chu, doctorate
Outcome results
None listed