RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
Boston Scientific Corporation
Summary
The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this study will be used to guide development and refinement of new software features that may be implemented in future commercial software releases.
Description
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 Bost…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 cath…
Interventions
- DeviceRhythmia Mapping System
The Rhythmia Mapping System is a 3D electro-anatomical mapping system.
Locations (8)
- University of Alabama at BirminghamBirmingham, Alabama
- St. Lukes Idaho Cardiology AssociatesBoise, Idaho
- Lahey Clinic, Inc.Burlington, Massachusetts
- Cardiovascular Specialists of New England Research FoundationLondonderry, New Hampshire
- Catholic Medical CenterManchester, New Hampshire
- Valley HospitalRidgewood, New Jersey