Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation (RECOVER AF)

Although much has been learned about the mechanisms of AF, they are not
completely understood. Because of this, in the great majority of AF patients,
it is not yet possible to precisely tailor an ablation strategy to a particular
AF mechanism.

Three-dimensional (3D) electroanatomical contact and noncontact mapping systems
have been reported to facilitate ablation of AF by identifying anatomical
structures and highlighting the location of ablated sites. This can guide the
initial ablation and help identify existing gaps in an incomplete lesion set.
Additionally, electromagnetic navigation systems have been shown to
substantially reduce the fluoroscopy time required for AF ablation.

The AcQMap*® High Resolution Imaging and Mapping System (AcQMap System) has
been designed to provide information on cardiac dipole densities as a function
of time and project that information on an image of a cardiac chamber. In this
study, the AcQMap* System will collect data from the AcQMap* 3D Imaging and
Mapping Catheter (AcQMap* Catheter) to create anatomical reconstructions of the
chamber(s) being mapped and to create Dipole Density maps on those
reconstructions. These maps will then be used to identify mechanisms of atrial
fibrillation, which can be targeted for ablation.

The objective of the study is to evaluate the performance and efficiency of the
AcQMap Imaging and Mapping System in an ablation retreatment procedure for
recurrent atrial fibrillation following a failed AF ablation

A prospective, single-arm, multi-center, multi-national, nonrandomized,
post-market study designed to provide clinical data regarding the use of the
AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation
retreatment ablation procedure. The patient population includes men and women,
eighteen (18) years of age or older. The treatment plan must include evaluation
and ablation (as indicated) of pulmonary vein reconnections plus AcQMap* guided
non-PV substrate ablation. Subject assessments will occur at screening,
procedure, hospital discharge, 3-, 6-, and 12-months.

The AcQMap* System provides automatic and instantaneous 3D displays of the
chamber surface and Dipole Density maps on that surface, which may be able to
identify mechanisms of atrial arrhythmias that cannot be identified using
standard tools. This has the potential of improving ablation efficiency and
shortening procedure time. This may also prove to be more effective at
verifying an appropriate endpoint to the ablation. This may provide the
Investigator with an intuitive tool to rapidly identify and guide treatment of
clinically-relevant targets for ablation. This may also positively impact
long-term outcomes of maintaining sinus rhythm in the future.

There is; however, no guarantee that this will occur. Through the subject*s
participation in this study, the information gathered will add to the
understanding of Dipole Density Mapping. This knowledge may advance medical
science and may benefit future subjects, as well as society at large.

Pre-clinical research and ongoing clinical studies have demonstrated that the
system is safe for human use. All potential risks have been evaluated and
mitigation strategies have been implemented to reduce potential risks to
acceptable levels. Acutus Medical believes that the potential benefits of the
system outweigh the potential risks.