AFL-EU: AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU)
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
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: The AcQBlate® Force Sensing Ablation System
Percutaneous catheter ablation of the cavotricuspid isthmus
|
Outcome Measures
Primary Outcome Measures
- Subjects free from procedure/device related Serious Adverse Events (SAEs) [7 days]
Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
- Subjects achieving acute procedural success [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
Criteria
Inclusion Criteria:
-
Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter.
-
At least one (1) documented episode of typical atrial flutter within 180 days (6 months) prior to enrollment, documented by 12-lead ECG.
-
Age 18 years or older at time of consent.
-
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:
-
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).
-
Inability to entrain CTI dependent AFL by standard pacing at procedure.
-
Any prior right atrial cavotricuspid isthmus ablation.
-
Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment.
-
Any patient scheduled or anticipating an AF ablation within the follow-up period.
-
Use of amiodarone within 120 days prior to procedure.
-
Cardiac surgery within 60 days prior to enrollment.
-
ST-elevation myocardial infarction (STEMI) within 60 days prior to enrollment
-
Current unstable angina.
-
Documented atrial or ventricular tumors, clots, thrombus, within 30-days prior to enrollment.
-
Any history of a known hematologic disorder (bleeding/clotting).
-
Implantation of permanent leads of an implantable device in or through the right atrium within 90-days prior to enrollment.
-
Subjects with New York Heart Association (NYHA) Class IV heart failure within 6-months prior to enrollment.
-
Subjects with an ejection fraction less than 30% within 90 days of enrollment.
-
Percutaneous Transluminal Coronary Angioplasty (PTCA) within 30-days of enrollment.
-
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.
-
Any cerebral ischemic/infarct event (excluding transient ischemic attacks) within 180 days prior to enrollment.
-
Body Mass Index (BMI) >42 kg/m2.
-
International Normalized Ratio (INR) > 3.
-
Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg) within the last 30-days.
-
Women who are pregnant or plan to become pregnant within the course of their participation in the investigation.
-
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.
-
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ZNA Middelheim | Antwerp | Belgium | 2020 | |
| 2 | Jessa Ziekenhuis | Hasselt | Belgium | 3500 | |
| 3 | James Cook University Hospital | Middlesbrough | United Kingdom | TS4 3BW |
Sponsors and Collaborators
- Acutus Medical
Investigators
- Study Chair: James Daubert, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLP-21-EU