RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Boston Scientific Corporation
- Study ID
- NCT03053141
- Status
- Recruiting
Conditions
- Cardiac Arrythmias
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rhythmia Mapping System — DEVICEThe Rhythmia Mapping System is a 3D electro-anatomical mapping system.
Study Details
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.
Key Dates
- Start date
- May 31, 2016
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: All SubjectsAll subjects are included in this cohort and are treated with the Rhythmia Mapping System
Primary Outcome Measure
Physician Feedback on Software Performance [ Time Frame: 1 day- Procedure ]
Central Contacts
- Susan Hampson5087285165
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | - |
| St. Lukes Idaho Cardiology Associates | Boise | Idaho | 83712 | - |
| Lahey Clinic, Inc. | Burlington | Massachusetts | 01805 | - |
| Cardiovascular Specialists of New England Research Foundation | Londonderry | New Hampshire | 03053 | Jennifer Driscoll, RN, BSN Jamie Kim, MD (PRINCIPAL_INVESTIGATOR) |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | - |
| Valley Hospital | Ridgewood | New Jersey | 07450-2736 | - |
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