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

Last updated: July 11, 2024
Sponsor: Yantai Yuhuangding Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Dysrhythmia

Treatment

STABLE-AF

STABLE-SR

CPVI

Clinical Study ID

NCT06499818
2024-226
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients age is 18-80 years;

  2. Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustainedepisode lasting > 7 days;

  3. Patients can sign the written informed consent for the study;

  4. Patients can endure the required follow-up.

Exclusion

Exclusion Criteria:

  1. Patients who had previously undergone atrial fibrillation, atrial tachycardia, oratypical 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 mitralstenosis, 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

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: STABLE-AF
Phase:
Study Start date:
July 15, 2024
Estimated Completion Date:
December 15, 2026