Clinical trial NCT06729866: EGM Guided PFA for PerAF
Official title: Electrogram Guided Pulse Field Ablation for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: eletrogram guided ablation
pulse field ablation
persistent atrial fibrillation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.
Primary purpose: TREATMENT

Brief summary: Pulse field ablation (PFA) has shown safety and efficacy in paroxysmal atrial fibrillation (AF), while the application in persistent atrial fibrillation (PerAF) is still under investigation. The investigators' previous randomized controlled trial showed favorable outcomes with electrogram (EGM) guided radiofrequency ablation in PerAF. However, EGM-guided PFA has not yet been reported.

Detailed description: Multiple studies have confirmed that pulse field ablation (PFA) demonstrates superior safety and efficacy in pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF). However, the application of PFA in persistent atrial fibrillation (PerAF) remains in the exploratory stages. The efficacy and safety of PFA across various ablation strategies require a comprehensive evaluation. Notably, electrogram (EGM) guided PFA ablation for persistent atrial fibrillation has not yet been reported in the literature.

In the investigators' previous study on radiofrequency ablation for PerAF, the investigators observed that EGM guided ablation yielded a high success rate. Furthermore, the investigators' recent research has confirmed that intraoperative termination of atrial fibrillation using EGM guided ablation is associated with favorable long-term outcomes in patients with PerAF.

The investigators aim to explore the preliminary application of EGM guided pulse field ablation (PFA) in persistent atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:

   1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent
   2. ECG-documented episode of persistent AF lasting longer than 7 days
   3. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
2. Patients who are ≥ 18 years
3. Patient participation requirements:

   1. Is willing and capable of providing Informed Consent to undergo study procedures
   2. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion Criteria:

1. AF that is:

   1. Paroxysmal (longest AF episode \< 7days)
   2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
2. Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
3. Any of the following cardiac conditions:

   1. Clinically significant arrhythmias other than AF, AFL or AT
   2. NYHA Class IV CHF
   3. Atrial or ventricular septal defect closure
   4. Atrial myxoma
   5. History of congenital heart disease with any residual anatomic or conduction abnormality
4. Any of the following within 3 months of enrollment:

   1. Myocardial infarction
   2. Unstable angina
   3. Percutaneous coronary intervention
   4. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)
   5. Heart failure hospitalization
   6. Stroke or TIA
   7. Clinically significant bleeding
   8. Pericarditis or pericardial effusion
   9. Left atrial thrombus
5. History of blood clotting or bleeding abnormalities.
6. Contraindication to, or unwillingness to use, systemic anticoagulation
7. Sensitivity to contrast media not controlled by premedication
8. Women of childbearing potential who are pregnant, lactating or not using birth control
9. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to

   1. Body mass index (BMI) \> 40 transplant
   2. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
   3. Renal insufficiency with an estimated creatinine clearance \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
   4. Active malignancy or history of treated cancer within 24 months of enrollment
   5. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
   6. Clinically significant infection
   7. Predicted life expectancy less than one year
10. Current or anticipated enrollment in any other clinical study

Primary outcomes:
measure: freedom from any AF/AT
timeFrame: freedom from any AF/AT at 3 months, 6 months and 12 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures.
measure: composite of major safety events
timeFrame: adverse events occurring within 30 days of the index or reassessment procedures.
Secondary outcomes:
measure: AF recurrence;
timeFrame: freedom from any AF at 3 months, 6 months and 12 months respectively after the procedure;
measure: AT recurrence
timeFrame: freedom from any AT at 3 months, 6 months and 12 months respectively after the procedure;
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: