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

Study Description

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
• Actual Study Start Date: March 25, 2021
• Actual Primary Completion Date: May 12, 2022
• Estimated Study Completion Date: September 28, 2022

Arms and Interventions

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: AcQBlate® Force Sensing Ablation System; Percutaneous catheter ablation of the cavotricuspid isthmus; Other Names: AcQBlate Force Sensing System; AcQBlate Force

Outcome Measures

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.

Eligibility Criteria

• 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).

Contacts and Locations

Locations

United States, Florida

Celebration Hospital

Orlando, Florida, United States, 32803

United States, Kentucky

Baptist Lexington Medical Center

Lexington, Kentucky, United States, 40503

United States, Maryland

Adventist Healthcare | White Oak Medical Center

Silver Spring, Maryland, United States, 20904

United States, Ohio

ProMedica Physician Cardiology

Toledo, Ohio, United States, 43615

Sponsors and Collaborators

Acutus Medical

More Information

• Responsible Party: Acutus Medical
• ClinicalTrials.gov Identifier: NCT04658940
• Obsolete Identifiers: NCT04657055
• Other Study ID Numbers: CLP-21
• First Posted: December 9, 2020
• Last Update Posted: August 3, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Atrial Flutter; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes