RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

The Rhythmia Mapping System is designed for electroanatomical mapping in catheter ablation
procedures by optimizing the need for speed and accuracy. The system is able to
simultaneously acquire data from multiple electrodes. In addition, based on user-defined
criteria, the system is able to efficiently acquire data over multiple cardiac beats. When
used in conjunction with the Rhythmia Mapping Catheter, the system is able to acquire up to
hundreds of points per minute leading to fast and detailed map creation.

Since its market release, physicians and users have gained experience with the Boston
Scientific Rhythmia Mapping System in the human clinical setting. Improvements to the first
generation system are in development and include new and improved software features and
mapping algorithms to enhance the clinical operation. These new and improved software
features and algorithms require leveraging clinical use data as part of the development and
iteration process.

This study will evaluate the performance of potential next-generation software features in a
low-risk clinical environment by streaming raw signals from a commercial Rhythmia Workstation
during standard of care cardiac mapping and ablation treatments for tachyarrhythmias,
specifically atrial fibrillation, atrial tachycardias, and ventricular tachycardia. The data
will be evaluated on a parallel investigational Rhythmia Workstation using prototype software
features. These next-generation software features and algorithms will not be available to the
physician during the case and will therefore have no diagnostic or therapeutic impact on the
clinical case.

Inclusion Criteria:

1. Age 18 or above, or above legal age and willing and capable of giving informed consent
specific to national law

2. Scheduled for standard of care catheter-based endocardial mapping for atrial or
ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.

Exclusion Criteria:

1. Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia

2. Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia, allergy,
etc.)

3. Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or
in the path of the catheter access route

4. Active systemic infection or sepsis

5. Hemodynamic instability or shock at baseline precluding ablation in the assessment of
the investigator.

6. Presence of intracardiac thrombus, tumor, or other abnormality which precludes
catheter introduction

7. Women who are pregnant or lactating

8. Cardiac surgery within the past 90 days

9. Acute myocardial infarction within 3 months

10. Stable/unstable angina or ongoing myocardial ischemia

11. Subjects with an active heart failure decompensation

12. Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes

13. Congenital heart disease with or without corrective surgery that would complicate a
mapping procedure

14. Subjects having untreatable allergy to contrast media

15. Vascular pathology or tortuosity precluding standard vascular access techniques

16. Subjects who are currently enrolled in another investigational study or registry that
would directly interfere with the current study, except when the patient is
participating in a mandatory governmental registry, or a purely observational registry
with no associated treatments. Each instance should be brought to the attention of the
sponsor to determine eligibility.