Prospective Registry on User Experience With The Mapping System For Ablation Procedures

The TRUE HD Study is aimed at collecting real-world data on the use of the Rhythmia mapping
system and the IntellaMap Orion mapping catheter in patients indicated for ablation procedure
with use of a 3D Mapping system.

The study will collect specific information on management of ablation procedures with the
commercial system including but not limited to acute procedural success, type and proportion
of arrhythmias mapped/treated, and how mapping system is used overall. Usage data may be used
for the planning of future clinical trials.

Inclusion Criteria:

- Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping
system and IntellaMap Orion mapping catheter according to current international and
local guidelines (and future revisions) and per physician discretion;

- Subjects who are willing and capable of providing informed consent;

- Subjects who are willing and capable of participating in all testing associated with
this clinical investigation at an approved clinical investigational center;

- Subjects whose age is 20 years or above, or of legal age to give informed consent
specific to state and national law.

Exclusion Criteria:

- Subjects requiring de novo ablation of atrial fibrillation;

- Subjects who are currently enrolled in another investigational study or registry that
would directly interfere with the current study, except when the subject is
participating in a mandatory governmental registry, or a purely observational registry
with no associated treatments; each instance must be brought to the attention of the
sponsor to determine eligibility*;

- The subject is unable or not willing to complete follow-up visits and examination for
the duration of the study;

- Subjects who have undergone a previous cardiac ablation within 30 days prior to
enrollment;

- Unrecovered/unresolved Adverse Events from any previous invasive procedure;

- Women of childbearing potential who are, or plan to become, pregnant during the time
of the study (method of assessment upon physician's discretion).