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AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter) (AcQForce AFL)

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ClinicalTrials.gov Identifier: NCT04658940
Recruitment Status : Active, not recruiting
First Posted : December 9, 2020
Last Update Posted : August 3, 2022
Information provided by (Responsible Party):
Acutus Medical

Tracking Information
First Submitted Date  ICMJE December 2, 2020
First Posted Date  ICMJE December 9, 2020
Last Update Posted Date August 3, 2022
Actual Study Start Date  ICMJE March 25, 2021
Actual Primary Completion Date May 12, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
  • 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)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
Official Title  ICMJE AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
Brief Summary The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Typical Atrial Flutter
Intervention  ICMJE Device: AcQBlate® Force Sensing Ablation System
Percutaneous catheter ablation of the cavotricuspid isthmus
Other Names:
  • AcQBlate Force Sensing System
  • AcQBlate Force
Study Arms  ICMJE Experimental: Non-randomized
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
Intervention: Device: AcQBlate® Force Sensing Ablation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 17, 2021)
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE September 28, 2022
Actual Primary Completion Date May 12, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04658940
Other Study ID Numbers  ICMJE CLP-21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Acutus Medical
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Acutus Medical
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Acutus Medical
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP