A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation

Shanghai Chest Hospital480 enrolled

Overview

This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

480

Conditions

Atrial Fibrillation Cathter Ablation Endpoint

Interventions

Each center completes the ablation according to the above ablation procedure. The choice of ablation strategy is not restricted, but efforts should be made to achieve termination of AF during the ablation procedure. If cannot terminate AF for safety or other reasons involving difficulties to remap AFEGM or creating a complete conduction block despite the operator's best efforts, then direct current conversion (DCCV) was performed.

Prespecified-ablation GroupPROCEDURE

Each center completes the prespecified ablation according to the above ablation procedure. Although there is no restriction on the choice of ablation strategy, Ablation must be performed following the PVI plus strategy, which can be combined with one or more additional ablation procedures, but each ablation must achieve its own endpoints, such as bidirectional block of linear damage, posterior wall isolation, etc. After completing the preset ablation steps, DCCV will be performed. If AF is terminated after or during ablation, it is also considered the endpoint of ablation in this group, but the preset ablation steps must be completed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. . Age 18-80 years old. 2. . Patients undergoing a first-time ablation procedure for PersAF. 3. . Diagnosed as persistent AF according to the latest clinical guidelines. 4. . Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment. 5. . Patients must be able and willing to provide written informed consent to participate in this study. Exclusion Criteria: 1. . Uncontrolled congestive heart failure; 2. . History of severe valve disease and/or prosthetic valve replacement; 3. . Myocardial infarction or stroke within 6 months; 4. . Severe congenital heart disease; 5. . EF \<35%; 6. . Contrast agent allergy; 7. . The use of anticoagulant drugs is contraindicated; 8. . Severe lung disease; 9. . Left atrial thrombus confirmed by preoperative esophageal ultrasound; 10. . Contraindications for cardiac catheterization; 11. . Prior left atrial ablation (surgical or catheter); 12. . Have performed any cardiac surgery within 2 months; 13. . Poor general health; 14. . Life expectancy \< 12 months.

Outcomes

Primary Outcomes

freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period

All patients included in the study had no incidence of Atrial fibrillation (AF), atrial tachycardia (AT) or Atrial flutter (AFL) at 12 months after ablation, excluding the initial 3-month blank period