AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter) (NCT04658940) | Clinical Trial Compass
CompletedNot Applicable
AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
United States115 participantsStarted 2021-03-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
✕
What they're measuring
1
Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)