AcQBlate Force Sensing Ablation System EU Study for Atrial Fibrillation (AcQForce AF-EU)
Primary Purpose
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcQBlate® Force Sensing Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
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 symptomatic PAF or PerAF.
- Refractory to Antiarrhythmic Drug (AAD) treatment
- 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 or sepsis.
Continuous episodes of AF Duration:
- PAF: AF duration lasting longer than 7 days
- Persistent AF: AF duration lasting longer than 12-months.
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- An implantable cardiac defibrillator (ICD) or pacemaker.
- 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) < 40% based on transthoracic echocardiogram (TTE) within the previous 180-days.
- Left atrial size > 55 mm based on transthoracic echocardiogram (TTE) measurement of the anteroposterior diameter, parasternal long-axis view in M Mode and performed within the previous 180-days.
- Evidence of heart failure (NYHA Class III or IV)
- Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
- Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
- Coronary artery bypass graft (CABG) within the last 180-days or coronary angioplasty (PTCA) procedure within the last 90-days.
- Unstable angina or ongoing myocardial ischemia.
- Myocardial infarction within the previous 180-days (sub-endocardial infarct within previous 90-days).
- Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg) recorded within the last 30 days.
- Moderate or severe valvular heart disease (stenosis or regurgitation).
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
- Presence of a left atrial appendage occlusion device.
- Previous PV stenting or evidence of PV stenosis.
- Presence of Left Atrial Thrombus
- Body Mass Index (BMI) > 42 kg/m2
- Estimated Glomerular Filtration Rate (eGFR) of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
- History of blood clotting or bleeding disease.
- ANY prior history of documented cerebral infarct, or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
- History of chronic obstructive pulmonary disease (COPD) requiring oral or IV steroid use in the previous 12-months.
- History of obstructive sleep apnea not currently being treated.
- Pregnant or lactating (current or anticipated during study follow-up).
- Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study.
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Paroxysmal atrial fibrillation
Persistent atrial fibrillation
Arm Description
Subjects schedule for a de novo ablation of paroxysmal atrial fibrillation
Subjects schedule for a de novo ablation of persistent atrial fibrillation
Outcomes
Primary Outcome Measures
Proportion of subjects who are free from device and/or procedure related Major Adverse Events (MAEs)
Subjects free from a composite list of pre-specified procedure/device related Major
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
Freedom from recurrence of atrial arrhythmias
Secondary Outcome Measures
Recording and analysis of all identified serious adverse events/device effects
Recording of all serious adverse events/device effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04941391
Brief Title
AcQBlate Force Sensing Ablation System EU Study for Atrial Fibrillation
Acronym
AcQForce AF-EU
Official Title
AcQBlate Force Sensing Ablation System EU Study for Atrial Fibrillation (AcQForce AF-EU)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (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
Yes
5. Study Description
Brief Summary
The AcQForce AF-EU clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and performance of the AcQBlate Force Sensing System.
Detailed Description
The AcQForce AF-EU clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and performance of the AcQBlate Force Sensing System. The AcQForce AF-EU study is a post-market study that will be run in parallel with a US IDE study of similar design. Data will be combined to support a pre-market approval (PMA) application to the US Food and Drug Administration (FDA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two distinct, non-randomized cohorts of subjects will be included; a PAF population and a PerAF population
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paroxysmal atrial fibrillation
Arm Type
Experimental
Arm Description
Subjects schedule for a de novo ablation of paroxysmal atrial fibrillation
Arm Title
Persistent atrial fibrillation
Arm Type
Experimental
Arm Description
Subjects schedule for a de novo ablation of persistent atrial fibrillation
Intervention Type
Device
Intervention Name(s)
AcQBlate® Force Sensing Ablation System
Intervention Description
Catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein. Additional left and right atrial targets may be ablated as clinically indicated.
Primary Outcome Measure Information:
Title
Proportion of subjects who are free from device and/or procedure related Major Adverse Events (MAEs)
Description
Subjects free from a composite list of pre-specified procedure/device related Major
Time Frame
12 months
Title
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
Description
Freedom from recurrence of atrial arrhythmias
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Recording and analysis of all identified serious adverse events/device effects
Description
Recording of all serious adverse events/device effects
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 symptomatic PAF or PerAF.
Refractory to Antiarrhythmic Drug (AAD) treatment
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 or sepsis.
Continuous episodes of AF Duration:
PAF: AF duration lasting longer than 7 days
Persistent AF: AF duration lasting longer than 12-months.
Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
An implantable cardiac defibrillator (ICD) or pacemaker.
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) < 40% based on transthoracic echocardiogram (TTE) within the previous 180-days.
Left atrial size > 55 mm based on transthoracic echocardiogram (TTE) measurement of the anteroposterior diameter, parasternal long-axis view in M Mode and performed within the previous 180-days.
Evidence of heart failure (NYHA Class III or IV)
Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
Coronary artery bypass graft (CABG) within the last 180-days or coronary angioplasty (PTCA) procedure within the last 90-days.
Unstable angina or ongoing myocardial ischemia.
Myocardial infarction within the previous 180-days (sub-endocardial infarct within previous 90-days).
Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg) recorded within the last 30 days.
Moderate or severe valvular heart disease (stenosis or regurgitation).
Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
Presence of a left atrial appendage occlusion device.
Previous PV stenting or evidence of PV stenosis.
Presence of Left Atrial Thrombus
Body Mass Index (BMI) > 42 kg/m2
Estimated Glomerular Filtration Rate (eGFR) of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
History of blood clotting or bleeding disease.
ANY prior history of documented cerebral infarct, or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
History of chronic obstructive pulmonary disease (COPD) requiring oral or IV steroid use in the previous 12-months.
History of obstructive sleep apnea not currently being treated.
Pregnant or lactating (current or anticipated during study follow-up).
Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study.
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Dull, MS
Phone
442-232-6080
Email
craig.dull@acutus.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jerald L. Cox, PA
Phone
760-529-6310
Email
jerry.cox@actus.com
12. IPD Sharing Statement
Plan to Share IPD
No
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AcQBlate Force Sensing Ablation System EU Study for Atrial Fibrillation
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