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AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU) (AFL-EU)

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ClinicalTrials.gov Identifier: NCT04657055
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Acutus Medical

Brief Summary:
The Acutus Medical AcQForce Flutter-EU clinical study is a prospective, multi-center, non-randomized global study designed to confirm the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter. The AcQForce Flutter-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).

Condition or disease Intervention/treatment Phase
Typical Atrial Flutter Device: The AcQBlate® Force Sensing Ablation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU)
Actual Study Start Date : April 23, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
Experimental: Non-randomized
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
Device: The AcQBlate® Force Sensing Ablation System
Percutaneous catheter ablation of the cavotricuspid isthmus




Primary Outcome Measures :
  1. Subjects free from procedure/device related Serious Adverse Events (SAEs) [ Time Frame: 7 days ]
    Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)

  2. Subjects achieving acute procedural success [ Time Frame: 20 minutes post ablation ]
    Acute procedural success is defined as the demonstration of bidirectional cavotricuspid isthmus block at least 20 minutes following the last radiofrequency application at the cavotricuspid isthmus with the investigational System.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter.
  2. At least one (1) documented episode of typical atrial flutter within 180 days (6 months) prior to enrollment, documented by 12-lead ECG.
  3. Age 18 years or older at time of consent.
  4. Subjects are willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations.

Exclusion Criteria:

  1. In the opinion of the Investigator, any contraindication to the planned atrial ablation, including contraindications to anticoagulation therapy and any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, chronic kidney disease).
  2. Inability to entrain CTI dependent AFL by standard pacing at procedure.
  3. Any prior right atrial cavotricuspid isthmus ablation.
  4. Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment.
  5. Any patient scheduled or anticipating an AF ablation within the follow-up period.
  6. Use of amiodarone within 120 days prior to procedure.
  7. Cardiac surgery within 60 days prior to enrollment.
  8. ST-elevation myocardial infarction (STEMI) within 60 days prior to enrollment
  9. Current unstable angina.
  10. Documented atrial or ventricular tumors, clots, thrombus, within 30-days prior to enrollment.
  11. Any history of a known hematologic disorder (bleeding/clotting).
  12. Implantation of permanent leads of an implantable device in or through the right atrium within 90-days prior to enrollment.
  13. Subjects with New York Heart Association (NYHA) Class IV heart failure within 6-months prior to enrollment.
  14. Subjects with an ejection fraction less than 30% within 90 days of enrollment.
  15. Percutaneous Transluminal Coronary Angioplasty (PTCA) within 30-days of enrollment.
  16. Clinically significant structural heart disease (including moderate to severe tricuspid valve regurgitation, tricuspid valve stenosis, or tricuspid valve replacement; Ebstein's anomaly, or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator.
  17. Any cerebral ischemic/infarct event (excluding transient ischemic attacks) within 180 days prior to enrollment.
  18. Body Mass Index (BMI) >42 kg/m2.
  19. International Normalized Ratio (INR) > 3.
  20. Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg) within the last 30-days.
  21. Women who are pregnant or plan to become pregnant within the course of their participation in the investigation.
  22. 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.
  23. 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): NCT04657055


Contacts
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Contact: Jerald Cox, PA 762-529-6310 jerry.cox@acutus.com
Contact: Victoria Low, BS 858-472-6577 victoria.low@acutus.com

Locations
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Belgium
ZNA Middelheim Not yet recruiting
Antwerp, Belgium, 2020
Contact: Bruno Schwagten, MD       bruno.schwagten@zna.be   
Contact: Tanja Van Den Stock, RN       tanja.vandenstock@zna.be   
Principal Investigator: Bruno Schwagten, MD         
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Johan Vijgen, MD    +32 11 33 70 31    Johan.vijgen@jessazh.be   
Contact: Arne Janssen    +32 11 33 70 31    Arne.Janssen@jessazh.be   
Principal Investigator: Johan Vijgen, MD         
United Kingdom
James Cook University Hospital Not yet recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Simon James, MD       simon.james1@nhs.net   
Contact: Deborah Athorne, RN    +01642 282410    deborah.athorne@nhs.net   
Principal Investigator: Simon James, MD         
Sponsors and Collaborators
Acutus Medical
Investigators
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Study Chair: James Daubert, MD Duke University
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Responsible Party: Acutus Medical
ClinicalTrials.gov Identifier: NCT04657055    
Other Study ID Numbers: CLP-21-EU
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 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:
atrial flutter
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes