AcQForce Pulsed Field Ablation-CE (PFA-AF)

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Arrhythmia
• Intervention / Treatment: Device: Acutus Medical Pulsed Field Ablation System

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-randomized; All subjects will be ablated using the Acutus Medical Pulsed Field Ablation System (PFA System) in the management of their atrial fibrillation.	Device: Acutus Medical Pulsed Field Ablation System; All subjects will be treated using the Acutus Medical Pulsed Field Ablation System (PFA System) to treat their atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who are free from device/procedure related Major Adverse Events	The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 6-months.	6 months
Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)	The Primary Endpoint for efficacy is the number of subjects where ablation of each accessible pulmonary vein (PV) resulted in confirmation of electrical isolation of the pulmonary vein (PVI) 20 minutes following the last index PFA/RF application with the investigational device	20 minutes post ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of all identified SAEs, SADEs, and UADEs	The Secondary Endpoint for Safety is a recording and analysis of all identified serious adverse events (SAEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs).	12 months
Subjects with freedom from an atrial arrhythmia	The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 12-months post index procedure	12 months

Collaborators and Investigators

• Sponsor: Acutus Medical
• Investigators: Principal Investigator: Petr Neuzil, MD, Na Homolce Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation; pulsed field ablation (PFA)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLP-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No