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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: CPVI; Procedure: STABLE-SR; Procedure: STABLE-AF

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongxia Chu, doctorate; Phone Number: 15965165932; Email: chuhx1972@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STABLE-SR	Procedure: STABLE-SR; homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm
Experimental: STABLE-AF	Procedure: STABLE-AF; homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation
Active Comparator: CPVI alone	Procedure: CPVI; ablate around the pulmonary vein orifice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of no atrial arrhythmias greater than 30 seconds	The incidence of no atrial arrhythmias greater than 30 seconds	at least 18 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds	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 tachycardia/flutter exceeding 30 seconds	No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds	at least 18 months follow up
Atrial fibrillation load	Atrial fibrillation load	at least 18 months follow up
Procedure time	time that the patient spend in the procedure room	Surgical procedure
Ablation time	the total Ablation time, during CPVI and after CPVI	1 week after patient enrollment
Incidence of peri-procedural complications	stroke, PV stenosis, cardiac perforation, esophageal injury and death	at least 18 months follow up

Collaborators and Investigators

• Sponsor: Yantai Yuhuangding Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2024-226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No