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CLP-21 AcQForce - Acqblate Force Sensing Ablation System US IDE for Atrial Flutter

NCT04657055

AcQForce - Acqblate Force Sensing Ablation System US IDE for Atrial Flutter

Associated Conditions

Atrial Fibrillation

Principal Investigator

Sponsor

Acutus

The purpose of this study is to demonstrate the safety and efficacy of the Acutus Medical AcQBlate Force Sensing Ablation System when used to treat atrial flutter (AFL). The System is very similar to other devices that FDA has approved and are used to treat atrial flutter by delivering radiofrequency (RF) energy to the area of your heart the study Doctor is trying to treat. One unique difference is the material used at the tip of the catheter. Approved devices use platinum iridium and the AcQBlate FORCE catheter uses gold which may offer better conduction of energy to your heart tissue. The AcQBlate Force Sensing Ablation System includes an ablation catheter and devices used to operate the catheter. This includes a unit that measures the catheter force (called a force sensing module) the study Doctor is applying in your heart, an RF generator that delivers energy to the catheter and a pump that provides water (saline) that keeps the tip of the catheter cool (irrigation pump).

This study is currently enrolling.