Clinical trial NCT05113056: AcQForce Pulsed Field Ablation-CE
Official title: The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Arrhythmia
Atrial Fibrillation
Keywords: atrial fibrillation
ablation
pulsed field ablation (PFA)
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo ablation for atrial fibrillation.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of subjects who are free from device/procedure related Major Adverse Events
timeFrame: 6 months
measure: Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)
timeFrame: 20 minutes post ablation
Secondary outcomes:
measure: Analysis of all identified SAEs, SADEs, and UADEs
timeFrame: 12 months
measure: Subjects with freedom from an atrial arrhythmia
timeFrame: 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
Study officials:
affiliation: Na Homolce Hospital
name: Petr Neuzil, MD
role: PRINCIPAL_INVESTIGATOR
References: