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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04941391
Recruitment Status : Not yet recruiting
First Posted : June 28, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Acutus Medical

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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Device: AcQBlate® Force Sensing Ablation System Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two distinct, non-randomized cohorts of subjects will be included; a PAF population and a PerAF population
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AcQBlate Force Sensing Ablation System EU Study for Atrial Fibrillation (AcQForce AF-EU)
Estimated Study Start Date : November 30, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Proportion of subjects who are free from device and/or procedure related Major Adverse Events (MAEs) [ Time Frame: 12 months ]
    Subjects free from a composite list of pre-specified procedure/device related Major

  2. Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period [ Time Frame: 12 months ]
    Freedom from recurrence of atrial arrhythmias


Secondary Outcome Measures :
  1. Recording and analysis of all identified serious adverse events/device effects [ Time Frame: 12 months ]
    Recording of all serious adverse events/device effects



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:

  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).

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): NCT04941391


Contacts
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Contact: Craig Dull, MS 442-232-6080 craig.dull@acutus.com
Contact: Jerald L. Cox, PA 760-529-6310 jerry.cox@actus.com

Sponsors and Collaborators
Acutus Medical
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Responsible Party: Acutus Medical
ClinicalTrials.gov Identifier: NCT04941391    
Other Study ID Numbers: CLP-16-EU
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acutus Medical:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes