CPVI Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: CPVI; Procedure: STABLE-SR; Procedure: STABLE-AF

• Registration Number: NCT06499818
• Lead Sponsor: Yantai Yuhuangding Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-07
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study Start: 2024-07-15
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2026-07-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPVI alone	CPVI	-
STABLE-SR	STABLE-SR	-
STABLE-AF	STABLE-AF	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Procedure time	Surgical procedure	time that the patient spend in the procedure room
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