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AcQBlate Force Confirmatory Study for Atrial Arrhythmias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429464
Recruitment Status : Withdrawn (Due to restrictions related to COVID the sponsor has decided not to move forward with this study)
First Posted : June 12, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Acutus Medical

Brief Summary:
AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)

Condition or disease Intervention/treatment Phase
Atrial Arrhythmias Device: AcQBlate Force Sensing Ablation Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo or repeat left-sided atrial ablation for symptomatic paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PerAF).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

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




Primary Outcome Measures :
  1. Subjects that demonstrate electrical isolation of the intended ablation [ Time Frame: At the end of their ablation procedure ]
    The Primary Endpoint for Performance is an analysis of the proportion of subjects that demonstrate electrical isolation (block) of the intended ablation targets.

  2. Proportion of subjects who are free from device/procedure related Major Adverse Events [ Time Frame: Through 30-days post procedure ]
    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.


Secondary Outcome Measures :
  1. Subjects with freedom from an atrial arrhythmia [ Time Frame: 30-days post index procedure ]
    The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 30-days post index procedure.

  2. Analysis of all identified SAEs, SADEs, and UADEs. [ Time Frame: Through 30-days post procedure ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429464


Locations
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Czechia
Na Homolce Hospital
Prague, Czechia, 150 30
Sponsors and Collaborators
Acutus Medical
Investigators
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Principal Investigator: Petr Neuzil, MD Na Homolce Hospital
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Responsible Party: Acutus Medical
ClinicalTrials.gov Identifier: NCT04429464    
Other Study ID Numbers: CLP-14
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Acutus Medical:
ablation
atrial arrhythmia
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes