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 — DEVICE
    The 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 Subjects
    All 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

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
St. Lukes Idaho Cardiology AssociatesBoiseIdaho83712-
Lahey Clinic, Inc.BurlingtonMassachusetts01805-
Cardiovascular Specialists of New England Research FoundationLondonderryNew Hampshire03053
Jennifer Driscoll, RN, BSN
Jamie Kim, MD (PRINCIPAL_INVESTIGATOR)
Catholic Medical CenterManchesterNew Hampshire03102-
Valley HospitalRidgewoodNew Jersey07450-2736-

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