EGM Guided PFA for PerAF | NCT06729866

NCT06729866

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electrogram guided pulse field ablation	Experimental	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.	Procedure: electrogram guided pulse field ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electrogram guided pulse field ablation	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
freedom from any AF/AT	The feasibility primary endpoint was defined as freedom from any AF/AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 3 months, 6 months and 12 months respectively after the procedure.	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.
composite of major safety events	The safety endpoint is a composite of major safety events including cardiac tamponade or perforation, peripheral or organ thromboembolism, stroke or transient ischemic attack (TIA), diaphragmatic paralysis, block, pericarditis, hemolysis, myocardial infarction, PV stenosis, atrioesophageal fistula, and death. The endpoint includes events occurring within 30 days of the index or reassessment procedures.	adverse events occurring within 30 days of the index or reassessment procedures.

Secondary Outcomes

Measure	Description	Time Frame
AF recurrence;	freedom from any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment at 3 months, 6 months and 12 months respectively	freedom from any AF at 3 months, 6 months and 12 months respectively after the procedure;
AT recurrence

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Patients who are ≥ 18 years
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:

AF that is:
1. Paroxysmal (longest AF episode < 7days)
2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
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
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
History of blood clotting or bleeding abnormalities.
Contraindication to, or unwillingness to use, systemic anticoagulation
Sensitivity to contrast media not controlled by premedication
Women of childbearing potential who are pregnant, lactating or not using birth control
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
Current or anticipated enrollment in any other clinical study

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes