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

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).

Study Overview

• Status: Completed
• Conditions: Typical Atrial Flutter
• Intervention / Treatment: Device: The AcQBlate® Force Sensing Ablation System

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jerald Cox, PA; Phone Number: 762-529-6310; Email: jerry.cox@acutus.com
• Study Contact Backup: Name: Victoria Low, BS; Phone Number: 858-472-6577; Email: victoria.low@acutus.com

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis
• United Kingdom
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects free from procedure/device related Serious Adverse Events (SAEs)	Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)	7 days
Subjects achieving acute procedural success	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.	20 minutes post ablation

Collaborators and Investigators

• Sponsor: Acutus Medical
• Investigators: Study Chair: James Daubert, MD, Duke University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2021
• Primary Completion (ACTUAL): May 12, 2022
• Study Completion (ACTUAL): June 12, 2022

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: atrial flutter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: CLP-21-EU (Other Identifier: Acutus Medical, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No