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

Yantai Yuhuangding Hospital

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: STABLE-SR; Procedure: CPVI; Procedure: STABLE-AF

Study type: Interventional

Funder types: Other

Identifiers

NCT06499818

2024-226

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

STABLE-SR

Experimental group

Treatment:

Procedure: STABLE-SR

STABLE-AF

Experimental group

Treatment:

Procedure: STABLE-AF

CPVI alone

Active Comparator group

Treatment:

Procedure: CPVI