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

Official title

Linear Ablation Added to Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone Using Pulsed Field Ablation for Persistent Atrial Fibrillation: a Multi-center Randomized Controlled Trial

Overview

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)

Detailed description

This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to PVI outperforms PVI alone using PFA in maintaining sinus rhythm for PerAF. Enrolled subjects will be randomized by the ratio of 1:1 into PVI and linear ablation arm or PVI alone arm. Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device and EIVOM could be performed additionally before or after PFA at the operator's discretion, it is recommended to perform EIVOM first. Subjects randomized to the PVI alone arm will undergo PVI only. If atrial fibrillation (AF) cannot be terminated during ablation, cardioversion will be performed. After ablation, all the subjects will be followed at discharge, 1 month and then at 3-month intervals up to 12 months.

Interventions

• Procedure Linear ablation
  Linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device.EIVOM could be performed additionally before or after PFA at the operator's discretion.
• Procedure PVI alone
  Undergo PVI with the study device

Primary outcome measures

• Primary Effectiveness Endpoint with Treatment Success. [Time frame: Completion of treatment 360 days compared with the baseline]
• Primary Safety Endpoint with Safety events related to AF catheter ablation. [Time frame: Completion of treatment 360 days compared with the baseline]

Secondary outcome measures (2)

• Secondary Effectiveness Endpoint with Chronic Success. [Time frame: Completion of treatment 360 days compared with the baseline.]
• Secondary Safety Endpoint with Non-SAE. [Time frame: Completion of treatment 360 days compared with the baseline]

Eligibility criteria

Inclusion criteria

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

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

• Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
• Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
• 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.
• Subjects undergoing a first-time ablation procedure for AF.
• Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.

Exclusion criteria

• AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
• Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
• Heart failure with left ventricular ejection fraction (LVEF) < 30% by TTE within 3 months prior the procedure.
• 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.
• 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.
• Any of the following events within 90 days of the Consent Date:

• Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery
• Pericarditis or symptomatic pericardial effusion
• Gastrointestinal bleeding
• Stroke, transient ischemic attack (TIA), or intracranial bleeding or any non-neurologic thromboembolic event
• Contraindication to, or unwillingness to use systemic anticoagulation.
• Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
• Women of childbearing potential who are pregnant or lactating.
• 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.
• 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.
• Predicted life expectancy less than 12 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Anzhen Hospital, affiliated to Capital Medical University — Beijing

Identifiers

NCT: NCT07106970 · PF336

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗