AcQForce Pulsed Field Ablation-CE

Atrial Fibrillation Clinical Trial

— PFA-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113056
• Other study ID #: CLP-23
• Status: Completed
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: March 16, 2023

Study information

• Verified date: November 2023
• Source: Acutus Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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