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

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

Tracking Information

• First Submitted Date: December 2, 2020
• First Posted Date: December 9, 2020
• Last Update Posted Date: August 3, 2022
• Actual Study Start Date: March 25, 2021
• Actual Primary Completion Date: May 12, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Typical Atrial Flutter

Intervention

Device: AcQBlate® Force Sensing Ablation System

Percutaneous catheter ablation of the cavotricuspid isthmus

Other Names:

• AcQBlate Force Sensing System
• AcQBlate Force

Study Arms

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 17, 2021): 100
• Original Enrollment: Not Provided
• Estimated Study Completion Date: September 28, 2022
• Actual Primary Completion Date: May 12, 2022 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04658940
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Acutus Medical
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Acutus Medical
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Acutus Medical
• Verification Date: August 2022