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Pulsed Field Ablation (PFA) Vs Anti-Arrhythmic Drug (AAD) Therapy As a First Line Treatment for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.
Study details:
This is a prospective, randomized, multi-center, global, pivotal Investigational device exemption (IDE) study. Subjects with persistent atrial fibrillation will be randomized or assigned to either pulsed field ablation (PFA) or Versus Anti-Arrhythmic Drug (AAD) treatment. Once randomization is complete, additional subjects will be enrolled and sequentially assigned to receive PFA treatment to fulfill the number of subjects required for the Primary Safety Endpoint assessment.
These additional subjects are referred to as PFA Assigned (Non-Roll-In) Subjects. Subjects randomized or assigned to PFA treatment will undergo percutaneous ablative pulmonary vein isolation (PVI) and left atrial posterior wall isolation (PWI) using the FARAWAVE™ PFA Catheter (first-line ablation cohort). Subjects randomized to AAD treatment will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF).
In the case of clinical inefficacy, the AAD dose will be up-titrated to the maximum tolerated dose. Thereafter, a change to a second or to a third AAD should be undertaken, insofar as the subject remains within the blanking period, with the goal to completely suppress AF episodes ≥ 30 seconds in duration. If AAD treatment is proven to be ineffective or intolerable outside of the blanking period, subjects can undergo subsequent ablation therapy and be considered part of the "delayed ablation cohort".
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-28
Primary completion: 2025-12-25
Study completion finish: 2027-12-30
Study type
TREATMENT
Phase
NA
Trial ID
NCT06096337
Intervention or treatment
DEVICE: FARAPULSE™ Pulsed Field Ablation (PFA) System
DRUG: Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
Conditions
- • Persistent Atrial Fibrillation
Find a site
Closest Location:
The Prince Charles Hospital
Research sites nearby
Select from list below to view details:
The Prince Charles Hospital
Chermside, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Royal Adelaide Hospital-Hospital
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Pulsed Field Ablation (PFA)
| DEVICE: FARAPULSE™ Pulsed Field Ablation (PFA) System
|
ACTIVE_COMPARATOR: Anti-Arrhythmic Drug (AAD)
| DRUG: Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Rate of randomized PFA or PFA Assigned subjects with PFA System inserted into the body, during the index or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious. | Defined Composite Adverse Events: Day 0 through Day 7: * Gastric motility / pyloric spasm disorders * Heart block * Myocardial infarction * Peripheral or organ thromboembolism * Pulmonary edema * Stroke/ Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Unresolved phrenic nerve palsy / paresis * Vascular access complications Day 0 through Day 30: * Cardiac tamponade / perforation * Cardiovascular or pulmonary adverse event * Death * Pericarditis Day 0 through Month 12: * Atrio-esophageal fistula * Pulmonary vein stenosis | 12-Months |
Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment. | Defined Treatment Success: PFA and AAD Treatment Arms: • Amiodarone freedom from randomization to Month 12 unless previously an acute or chronic primary effectiveness failure. PFA Treatment Arm: • Acute Success - Isolation of attempted pulmonary veins and left atrial posterior wall during blanking period with PFA system And Chronic Success: Freedom during blanking period to Month 12 of: * Occurrence ≥ 1 hr of asymptomatic or ≥ 30 sec of symptomatic Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Any re-ablation for AF, AFL, or AT * Any electrical cardioversion for AF, AFL, or AT * Any Class I or III AAD use AAD Treatment Arm: Acute Success - Ablation not performed in blanking period Chronic Success - Freedom after blanking period through Month 12 of: * Detectable occurrence ≥ 1 hr of asymptomatic or ≥ 30 sec of symptomatic AF, AFL, or AT * Electrical cardioversion for AF, AFL, or AT * Any ablation for AF, AFL, or AT | 12-Months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Atrial fibrillation burden between the pulsed field ablation and anti-arrhythmic drug arm, as the LUX-Dx Insertable Cardiac Monitor measures and defined as proportion of time individual spends in AF during a period (expressed as a percentage). | Atrial Fibrillation (AF) burden, measured by the LUX-Dx Insertable Cardiac Monitor (ICM) between the 2 randomized groups: * Pulsed Field Ablation (PFA) as initial treatment for subjects with persistent AF * Anti-Arrhythmic Drug (AAD) as initial treatment for subjects with persistent AF Defined AF Burden is proportion of AF time during a period (expressed as a percentage). | 12, 24, and 36 Months |
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