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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05113056
Other study ID # CLP-23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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