Back to resultsAcQForce Pulsed Field Ablation-CE (PFA-AF)
Primary Purpose
Atrial Arrhythmia, Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Acutus Medical Pulsed Field Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Arrhythmia focused on measuring atrial fibrillation, ablation, pulsed field ablation (PFA)
Eligibility Criteria
Inclusion Criteria:
- Male or female between the ages of 18 to 80 years at time of consent
- Clinically indicated and scheduled for a de novo catheter ablation of AF
- 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:
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
- Continuous episodes of AF duration lasting longer than 12-months
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
Structural heart disease or cardiac history as described below:
- Left ventricular ejection fraction (LVEF) < 35%
- Left atrial size > 60 mm
- Evidence of heart failure (NYHA Class III or IV)
- Unstable angina or ongoing myocardial ischemia
- Recent myocardial infarction
- Severe uncontrolled systemic hypertension
- Moderate or severe valvular heart disease (stenosis or regurgitation).
- 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.
- Body Mass Index (BMI) > 42 kg/m2
- History of blood clotting or bleeding disease.
- ANY prior history of documented cerebral infarct (stroke), or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
- History of obstructive sleep apnea not currently being treated.
- Pregnant or lactating (current or anticipated during study follow-up).
- 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).
Sites / Locations
- Na Homolce Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-randomized
Arm Description
All subjects will be ablated using the Acutus Medical Pulsed Field Ablation System (PFA System) in the management of their atrial fibrillation.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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).
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05113056
Brief Title
AcQForce Pulsed Field Ablation-CE
Acronym
PFA-AF
Official Title
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acutus Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Arrhythmia, Atrial Fibrillation
Keywords
atrial fibrillation, ablation, pulsed field ablation (PFA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-randomized
Arm Type
Experimental
Arm Description
All subjects will be ablated using the Acutus Medical Pulsed Field Ablation System (PFA System) in the management of their atrial fibrillation.
Intervention Type
Device
Intervention Name(s)
Acutus Medical Pulsed Field Ablation System
Intervention Description
All subjects will be treated using the Acutus Medical Pulsed Field Ablation System (PFA System) to treat their atrial fibrillation.
Primary Outcome Measure Information:
Title
Proportion of subjects who are free from device/procedure related Major Adverse Events
Description
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.
Time Frame
6 months
Title
Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)
Description
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
Time Frame
20 minutes post ablation
Secondary Outcome Measure Information:
Title
Analysis of all identified SAEs, SADEs, and UADEs
Description
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).
Time Frame
12 months
Title
Subjects with freedom from an atrial arrhythmia
Description
The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 12-months post index procedure
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female between the ages of 18 to 80 years at time of consent
Clinically indicated and scheduled for a de novo catheter ablation of AF
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:
In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
Continuous episodes of AF duration lasting longer than 12-months
Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
Structural heart disease or cardiac history as described below:
Left ventricular ejection fraction (LVEF) < 35%
Left atrial size > 60 mm
Evidence of heart failure (NYHA Class III or IV)
Unstable angina or ongoing myocardial ischemia
Recent myocardial infarction
Severe uncontrolled systemic hypertension
Moderate or severe valvular heart disease (stenosis or regurgitation).
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.
Body Mass Index (BMI) > 42 kg/m2
History of blood clotting or bleeding disease.
ANY prior history of documented cerebral infarct (stroke), or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
History of obstructive sleep apnea not currently being treated.
Pregnant or lactating (current or anticipated during study follow-up).
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD
Organizational Affiliation
Na Homolce Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
150 30
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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AcQForce Pulsed Field Ablation-CE
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