The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study.
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and efficacy of the AcQBlate Force Sensing System in the ablation treatment of symptomatic, drug-refractory atrial fibrillation in two subject cohorts: paroxysmal atrial fibrillation, and persistent atrial fibrillation. Data will be used to support pre-market approval applications (PMAs).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein. Additional left and right atrial targets may be ablated as clinically indicated.
Subjects who are free from device and/or procedure related Major Adverse Events (MAEs)
Subjects free from a composite list of pre-specified procedure/device related Major Adverse Events (MAEs)
Time frame: 12 months
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
Freedom from recurrence of atrial arrhythmias
Time frame: 12 months
Recording of all serious adverse events/device effects
Recording of all serious adverse events/device effects
Time frame: 12 months
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