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

Completed · Not applicable

Conditions studied: Typical Atrial Flutter

In brief

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.

Key facts

Study ID

NCT04658940

Run by

Acutus Medical

People needed

115

Starts

2021-03-25

Expected to finish

2022-06-12

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• AZ Cardiovascular Research Center — Phoenix, Arizona, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• John Muir Health — Concord, California, United States
• San Diego Cardiac Center Medical Group, Inc. — San Diego, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• BayCare Heath — Clearwater, Florida, United States
• Celebration Hospital — Orlando, Florida, United States
• Bayfront Health — St. Petersburg, Florida, United States
• St Alphonsus Health System — Boise, Idaho, United States
• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• Baptist Lexington Medical Center — Lexington, Kentucky, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• Adventist Healthcare | White Oak Medical Center — Silver Spring, Maryland, United States
• Adventist Healthcare, Inc — Silver Spring, Maryland, United States
• Weill Cornell — New York, New York, United States
• Ohio State Med Ctr — Columbus, Ohio, United States
• ProMedica Physician Cardiology — Toledo, Ohio, United States
• Penn State Health — Hershey, Pennsylvania, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• ZNA Middelheim — Antwerp, Belgium
• Jessa Ziekenhuis — Hasselt, Belgium
• James Cook University Hospital — Middlesbrough, United Kingdom
• Freeman Hospital — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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