AcQBlate Force Confirmatory Study for Atrial Arrhythmias

AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)

AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)

Study Overview

• Status: Withdrawn
• Conditions: Atrial Arrhythmias
• Intervention / Treatment: Device: AcQBlate Force Sensing Ablation Catheter

Detailed Description

Acutus Medical's AcQBlate Force Ablation Catheter when used in combination with the Qubic Force Sensing Module (AcQBlate Force System), is indicated for cardiac electrophysiological mapping, delivery of diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent atrial arrhythmias.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital

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:

• Male or female between the ages of 18 to 80 years at time of consent.
• Clinically indicated and scheduled for a de novo or repeat catheter ablation of PAF or PerAF
• Willing and able to provide written informed consent to 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 AF > 12-months (long-standing persistent AF)
• Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
• An implanted pacemaker or Implantable Cardiac Defibrillator (ICD).
• Structural heart disease or cardiac history as described below:
• Left ventricular ejection fraction (LVEF) < 35% based on transthoracic echocardiogram (TTE) within the previous 180-days.
• Left atrial size > 55 mm based on TTE 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) or coronary angioplasty (PTCA) procedure within the last 90-days.
• Unstable angina or ongoing myocardial ischemia.
• Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg recorded within the last 30-days.
• Moderate or severe tricuspid stenosis or regurgitation.
• Moderate or severe mitral 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
• Body Mass Index (BMI) >40 kg/m2
• History of blood clotting or bleeding disease.
• Any prior history of documented cerebral infarct or systemic embolism (excluding post- operative deep vein thrombosis (DVT)).
• Pregnant or lactating (current or anticipated during study follow up).
• Current enrollment in any other study protocol where testing or results from the 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-randomized; All subjects will be treated using the Acutus Medical's AcQBlate Force Sensing Ablation Catheter in combination with the Qubic Force Sensing Module (AcQBlate Force Sensing System) to treat their arrhythmia.	Device: AcQBlate Force Sensing Ablation Catheter; Confirmation that the AcQBlate Force System is safe and effective for the treatment of atrial arrhythmias

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects that demonstrate electrical isolation of the intended ablation	The Primary Endpoint for Performance is an analysis of the proportion of subjects that demonstrate electrical isolation (block) of the intended ablation targets.	At the end of their ablation procedure
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 30-days.	Through 30-days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects with freedom from an atrial arrhythmia	The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 30-days post index procedure.	30-days post index procedure
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) through 30-days post-procedure.	Through 30-days post procedure

Collaborators and Investigators

• Sponsor: Acutus Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): November 15, 2020
• Study Completion (Anticipated): November 15, 2020

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: ablation; atrial arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CLP-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes