PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)

Summary

This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)

Eligibility

Inclusion Criteria:

Study subjects are required to meet all the following inclusion criteria:

1. Subjects with an age range of 18 years or above and 80 years or below.
2. Subjects have symptomatic, drug-resistant, persistent AF, defined as:

   1. Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
   2. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
   3. Persistent: continuous AF for \> 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart.
3. Subjects undergoing a first-time ablation procedure for AF.
4. Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.

Exclusion Criteria:

1. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
2. Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
3. Heart failure with left ventricular ejection fraction (LVEF) \< 30% by TTE within 3 months prior the procedure.
4. LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure.
5. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, mechanical valve, interatrial baffle, closure device, patch, or patent foramen oval occlude, left atrial appendage closure at the time of ablation.
6. Any of the following events within 90 days of the Consent Date:

   1. Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery
   2. Pericarditis or symptomatic pericardial effusion
   3. Gastrointestinal bleeding
   4. Stroke, transient ischemic attack (TIA), or intracranial bleeding or any non-neurologic thromboembolic event
7. Contraindication to, or unwillingness to use systemic anticoagulation.
8. Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
9. Women of childbearing potential who are pregnant or lactating.
10. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \< 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant.
11. Conditions that in the investigator's medical opinion would interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
12. Predicted life expectancy less than 12 months.

Conditions2

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