Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

Official title

A Multicenter Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System in Patients With Atrial Fibrillation

Overview

This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).

Detailed description

The objective of this feasibility study is to:

* Evaluate the initial safety and acute performance of investigational waveform(s) delivered using the FARAPULSE™ PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF). * Assess the feasibility of the ablation workflow and waveform delivery. * Characterize acute and chronic lesion durability, procedure efficiency, and waveform exposure patterns.

Interventions

• Device FARAPULSE™ Pulsed Field Ablation (PFA) System
  The FARAWAVE™ PFA Catheter will be used to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARASTAR™ Generator will be used in conjunction with the FARAWAVE™ PFA Catheter to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARADRIVE™ Steerable Sheath will be us

Primary outcome measures

• Device or procedure-related Composite Adverse Events (CAEs) [Time frame: Ablation Procedure Day 0 - Day 7; Day 0 - Day 30; Day 0 - Day 60]
• Acute Procedural Success [Time frame: During the Ablation Procedure]

Eligibility criteria

Inclusion criteria

• ≥ 18 years of age, or older if required by local law
• Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation

• Persistent AF Documented:

• Physician's note confirming the presence of persistent atrial fibrillation and the arrhythmia symptoms
• Within 180 days prior to Enrollment: A 24-hour continuous ECG recording confirming continuous AF OR Two (2) ECGs from any regulatory-cleared rhythm monitoring device showing continuous AF taken at least 7 days apart.

OR

• Paroxysmal AF Documented:

• Physician's note confirming the presence of paroxysmal atrial fibrillation and the arrhythmia symptoms
• Within 180 days of the Enrollment Date, one (1) ECG from any regulatory-cleared rhythm monitoring device showing atrial Fibrillation (AF)
• Willing and capable of providing informed consent
• Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

Exclusion criteria

• Atrial exclusions - any of the following atrial conditions:

• Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter is not available, LA non-indexed volume > 100 mL. If both values are available, only the LA diameter will be used to confirm eligibility.
• Any prior atrial endocardial, epicardial, or surgical ablation procedure for arrhythmia other than ablation for right-sided SVT or cavotricuspid isthmus ablation
• Any prior atrial surgery
• Current atrial myxoma
• Current Left Atrial Thrombus
• Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
• Cardiovascular Conditions - Any of the following cardiovascular conditions:

• History of sustained ventricular tachycardia (VT) or any ventricular fibrillation (VF)
• Atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes
• Cardiac Devices and Implants:

• Current or anticipated pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy devices.
• Interatrial baffle, patent foramen ovale, or atrial septal defect closure device or patch.
• Any Left Atrial Appendage Closure or Occlusion Device, except a WATCHMAN™ device implanted > 90 days before Enrollment
• Valvular Disease - Presence of any of the following:

• Any prosthetic heart valve, ring or repair
• Moderate to severe mitral valve stenosis
• More than moderate mitral regurgitation (≥ 3+)
• Moderate to severe aortic stenosis
• Cardiomyopathy - Hypertrophic cardiomyopathy
• Access Issues - Any IVC filter, known inability to obtain vascular access, or other contraindication to femoral access
• Anticipated Cardiac Surgery - Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months
• Congenital Conditions - Any of the following congenital conditions:

a. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality

• Baseline Conditions - Any of the following conditions at Baseline:

• Heart failure - Heart failure associated with NYHA Class III or IV
• Ejection Fraction - Most recent documented LVEF < 40% within the previous 12 months
• Obesity: Body Mass Index (BMI) > 45.0 kg/m\^2
• Hematologic Condition: Known coagulopathy or bleeding disorder
• Anticoagulation Contraindication: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation
• Pregnancy - Women who are confirmed to be pregnant or lactating at the time of the ablation procedure
• Pulmonary Disease - Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
• Malignancy - Active malignancy (other than non-melanoma skin cancers)
• Gastrointestinal - Clinically significant gastrointestinal problems involving the esophagus or stomach, including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
• Infection - Known active systemic infection
• Sleep Apnea - Untreated diagnosed obstructive sleep apnea with apnea-hypopnea index classification of severe (> 30 events per hour) as per the guidelines
• Life Expectancy - Predicted life expectancy of less than one (1) year per investigator medical judgment
• Concurrent Enrollment - Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility
• Any of the following events within 90 days of the Consent Date:

• Coronary disease - Myocardial infarction (MI), unstable angina or coronary intervention
• Pericardium - Pericarditis or symptomatic pericardial effusion
• GI Bleeding - Gastrointestinal bleeding
• Cardiac Surgery - Any cardiac surgery
• Neurovascular Event - Stroke, TIA, or intracranial bleeding
• Thromboembolism - Any active non-neurologic thrombus and/or thromboembolic event
• Carotid Intervention - Carotid stenting or endarterectomy
• Diabetes - Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%
• Medical History - Any of the following conditions in the Medical History

• Transplantation - Solid organ or hematologic transplant, or currently being evaluated for a transplant
• Diaphragmatic Abnormality - Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
• Coronary Disease - Any documented history of Prinzmetal angina or severe non-revascularizable coronary disease
• Renal Disease - 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
• General Medical Conditions - Any other general health conditions that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Croatia · 1 center

• Klinicki Bolnicki Centar Split — Split

Czechia · 1 center

• Na Homolce Hospital — Prague

Hong Kong · 1 center

• Queen Mary Hospital — Hong Kong

Taiwan · 1 center

• Taipei Veterans General Hospital-Hospital — Taipei

Identifiers

NCT: NCT07444320 · PF119

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗