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

NCT06499818 | Not Yet Recruiting

• 1 other identifier: 2024-226
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  at least 18 months follow up

• Atrial fibrillation load

  at least 18 months follow up

• Procedure time

  Surgical procedure

• Ablation time

  1 week after patient enrollment

Study Arms (3)

STABLE-SR

EXPERIMENTAL

Procedure: STABLE-SR

STABLE-AF

EXPERIMENTAL

Procedure: STABLE-AF

CPVI alone

ACTIVE COMPARATOR

Procedure: CPVI

Interventions

STABLE-SR PROCEDURE

homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm

STABLE-SR

STABLE-AF PROCEDURE

homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation

STABLE-AF

CPVI PROCEDURE

ablate around the pulmonary vein orifice

CPVI alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age is 18-80 years;
• Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \> 7 days;
• Patients can sign the written informed consent for the study;
• Patients can endure the required follow-up.

You may not qualify if:

• Patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation
• Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter
• Left atrial diameter \>55mm
• Left ventricular ejection fraction \<35%
• Left atrial thrombus
• Postoperative cardiac surgery
• After valve replacement
• After permanent pacemaker implantation
• hypertrophic cardiomyopathy
• Patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease
• Hemorrhagic stroke within 6 months
• Transient ischemic attack or ischemic stroke within 1 month
• Mental disorder or history of mental illness and inability to cooperate voluntarily
• Breastfeeding, pregnancy and women planning or likely to become pregnant
• Life expectancy \<12 months

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hongxia Chu, doctorate

CONTACT

15965165932; chuhx1972@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 15, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-07