AcQBlate Force Sensing Ablation System EU Study for Atrial Fibrillation (AcQForce AF-EU)

AcQBlate Force Sensing Ablation System EU Study for Atrial Fibrillation (AcQForce AF-EU)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: AcQBlate® Force Sensing Ablation 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).

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 symptomatic PAF or PerAF.
3. Refractory to Antiarrhythmic Drug (AAD) treatment
4. 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 or sepsis.

2. Continuous episodes of AF Duration:

   1. PAF: AF duration lasting longer than 7 days
   2. Persistent AF: 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. An implantable cardiac defibrillator (ICD) or pacemaker.
5. Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.

6. Structural heart disease or cardiac history as described below:

   1. Left ventricular ejection fraction (LVEF) < 40% based on transthoracic echocardiogram (TTE) within the previous 180-days.
   2. 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.
   3. Evidence of heart failure (NYHA Class III or IV)
   4. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
   5. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
   6. Coronary artery bypass graft (CABG) within the last 180-days or coronary angioplasty (PTCA) procedure within the last 90-days.
   7. Unstable angina or ongoing myocardial ischemia.
   8. Myocardial infarction within the previous 180-days (sub-endocardial infarct within previous 90-days).
   9. Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg) recorded within the last 30 days.
   10. Moderate or severe valvular heart disease (stenosis or regurgitation).
   11. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
   12. Presence of a left atrial appendage occlusion device.
   13. Previous PV stenting or evidence of PV stenosis.
7. Presence of Left Atrial Thrombus
8. Body Mass Index (BMI) > 42 kg/m2
9. Estimated Glomerular Filtration Rate (eGFR) of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
10. History of blood clotting or bleeding disease.
11. ANY prior history of documented cerebral infarct, or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
12. History of chronic obstructive pulmonary disease (COPD) requiring oral or IV steroid use in the previous 12-months.
13. History of obstructive sleep apnea not currently being treated.
14. Pregnant or lactating (current or anticipated during study follow-up).
15. 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.
16. 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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paroxysmal atrial fibrillation; Subjects schedule for a de novo ablation of paroxysmal atrial fibrillation	Device: AcQBlate® Force Sensing Ablation System; 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.
Experimental: Persistent atrial fibrillation; Subjects schedule for a de novo ablation of persistent atrial fibrillation	Device: AcQBlate® Force Sensing Ablation System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period	Freedom from recurrence of atrial arrhythmias	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recording and analysis of all identified serious adverse events/device effects	Recording of all serious adverse events/device effects	12 months

Collaborators and Investigators

• Sponsor: Acutus Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLP-16-EU (Other Identifier: Acutus Medical, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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