Clinical trial NCT06633523: Optimized Posterior Left Atrial Wall Ablation Strategy for PeAF
Official title: Optimized Posterior Left Atrial Wall Ablation Strategy for Persistent Atrial Fibrillation: A Multicenter Large-Sample Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: pulmonary vein isolation
pulse field ablation
anatomical and potential-guided ablation
posterior left atrial wall ablation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Tongji Hospital affiliated to Tongji University
name: Shanghai 10th People&#39;s Hospital
name: Shanghai Sixth People&#39;s Hospital affiliated to Shanghai Jiao Tong University School Of Medicine
First posted: 2024-10-09
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).

Detailed description: This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).

The main content of the research includes comparing three approaches through randomization: pulmonary vein isolation (PVI) alone, PVI plus pulse field ablation (PWI), and PVI plus anatomical and potential-guided ablation, to evaluate their effects on reducing the recurrence rate of atrial fibrillation. The study is designed with three groups: the PVI-alone group, the PVI + PWI group, and the PVI plus anatomical and potential-guided ablation group.

Eligibility criteria: Inclusion Criteria

* Patients aged ≥18 years.
* Patients undergoing their first ablation procedure for PsAF.
* Persistent atrial fibrillation (AF): Defined as episodes lasting ≥7 days and ≤3 years (including those requiring pharmacological or electrical cardioversion ≥7 days).
* Atrial fibrillation symptoms that are intolerant to at least one antiarrhythmic drug (AAD).
* At least one episode of PsAF must have been documented within the last 2 years by methods such as ECG, Holter monitoring, loop recorder, telemetry, remote telemonitoring (TTM), or implanted devices prior to enrollment in this study.
* Patients must be capable and willing to provide written informed consent to participate in the study.
* Patients must be willing and able to comply with all study follow-up requirements.

Exclusion Criteria:

* Paroxysmal AF: Defined as episodes lasting \&lt;7 days (or resolved with medication/electrical cardioversion within \&lt;7 days).
* Patients with long-standing persistent AF: Defined as persistent AF lasting \&gt;3 years.
* Patients who have never attempted/pursued cardiac rhythm restoration or sinus rhythm.
* Contraindication to systemic anticoagulation.
* Pregnancy.
* Advanced renal or hepatic failure.
* Severe valvular heart disease or cyanotic congenital heart disease.
* Hypertrophic cardiomyopathy.

Primary outcomes:
measure: recurrence of atrial arrhythmias
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Secondary outcomes:
measure: no occurrence of any documented atrial fibrillation (AF) episode lasting more than 30 seconds
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: occurrence of any documented atrial arrhythmia lasting more than 30 seconds
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: the burden of atrial fibrillation at 12 months of follow-up between different study groups
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: no occurrence of any documented atrial arrhythmia lasting more than 30 seconds
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: no occurrence of any documented persistent atrial arrhythmia lasting more than 7 days
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: no occurrence of any documented symptomatic atrial fibrillation, flutter, or tachyarrhythmia lasting more than 30 seconds
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Procedure duration / Fluoroscopy time / Radiofrequency ablation time
timeFrame: Record the duration of the surgery, fluoroscopy time, and radiofrequency ablation time immediately after the completion of the radiofrequency ablation procedure, measured in hours.
measure: Posterior wall isolation success rate (bidirectional block).
timeFrame: Evaluate from the date of the procedure until the first documented recurrence of atrial arrhythmia, with a maximum assessment duration of 12 months.
measure: Number of repeat procedures within at least 12 months of follow-up
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Number of direct current (DC) cardioversions performed due to atrial fibrillation recurrence within at least 12 months of follow-up.
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Use of antiarrhythmic drugs at 3 months, at the time of atrial fibrillation recurrence, and at final follow-up.
timeFrame: Evaluate from 3 months post-procedure until the first documented recurrence of atrial fibrillation, with a maximum assessment duration of 12 months
measure: Perioperative complications
timeFrame: Perioperative period
measure: Quality of life assessments
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Quality of life assessments
timeFrame: At least 12 months of follow-up, beyond the initial 3-month blanking period.
measure: Psychological distress
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Functional status
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Cardiac functional capacity
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Chest Hospital
name: Xumin Hou, Doctor
role: PRINCIPAL_INVESTIGATOR
References: