RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) (RHAPSODY)
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|ClinicalTrials.gov Identifier: NCT03053141|
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment|
|Cardiac Arrythmias||Device: Rhythmia Mapping System|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||April 2020|
All subjects are included in this cohort and are treated with the Rhythmia Mapping System
Device: Rhythmia Mapping System
The Rhythmia Mapping System is a 3D electro-anatomical mapping system.
- Physician Feedback on Software Performance [ Time Frame: 1 day- Procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053141
|United States, Alabama|
|University of Alabama, Birmingham||Not yet recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Alicia Gunter firstname.lastname@example.org|
|Principal Investigator: Thomas H McElderry, MD|
|San Raffaele Hospital||Recruiting|
|Contact: Caterina Bisceglia, MD email@example.com|
|Principal Investigator: Paolo Della Bella, MD|
|Principal Investigator:||Thomas H McElderry, MD||University of Alabama at Birmingham|