AcQForce Pulsed Field Ablation-CE (PFA-AF)

Acutus Medical

Status: Completed

Conditions: Atrial Fibrillation; Atrial Arrhythmia

Treatments: Device: Acutus Medical Pulsed Field Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05113056

CLP-23

Details and patient eligibility

About

The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)

Full description

This clinical study is designed to evaluate the safety and performance of the PFA System in the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory submissions.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female between the ages of 18 to 80 years at time of consent
2. Clinically indicated and scheduled for a de novo catheter ablation of AF
3. Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.

Exclusion criteria

1. In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.

2. Continuous episodes of AF duration lasting longer than 12-months

3. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.

4. Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.

5. Structural heart disease or cardiac history as described below:

   1. Left ventricular ejection fraction (LVEF) < 35%
   2. Left atrial size > 60 mm
   3. Evidence of heart failure (NYHA Class III or IV)
   4. Unstable angina or ongoing myocardial ischemia
   5. Recent myocardial infarction
   6. Severe uncontrolled systemic hypertension
   7. Moderate or severe valvular heart disease (stenosis or regurgitation).
   8. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.

   l. Presence of a left atrial appendage occlusion device. j. Previous PV stenting or evidence of PV stenosis.

6. Body Mass Index (BMI) > 42 kg/m2

7. History of blood clotting or bleeding disease.

8. ANY prior history of documented cerebral infarct (stroke), or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).

9. History of obstructive sleep apnea not currently being treated.

10. Pregnant or lactating (current or anticipated during study follow-up).

11. Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Non-randomized

Experimental group

Description:

All subjects will be ablated using the Acutus Medical Pulsed Field Ablation System (PFA System) in the management of their atrial fibrillation.

Treatment:

Device: Acutus Medical Pulsed Field Ablation System