Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | All subjects are included in this cohort and are treated with the Rhythmia Mapping System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhythmia Mapping System | Device | The Rhythmia Mapping System is a 3D electro-anatomical mapping system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician Feedback on Software Performance | Physician Feedback on Software Performance | 1 day- Procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Hampson | Contact | 5087285165 | Susan.Hampson@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas H McElderry, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Completed | Birmingham | Alabama | 35233 | United States | |
Not provided
Not provided
Not provided
Not provided
| St. Lukes Idaho Cardiology Associates |
| Completed |
| Boise |
| Idaho |
| 83712 |
| United States |
| Lahey Clinic, Inc. | Completed | Burlington | Massachusetts | 01805 | United States |
| Cardiovascular Specialists of New England Research Foundation | Recruiting | Londonderry | New Hampshire | 03053 | United States |
|
| Catholic Medical Center | Completed | Manchester | New Hampshire | 03102 | United States |
| Valley Hospital | Completed | Ridgewood | New Jersey | 07450-2736 | United States |
| Fondazione Centro San Raffaele | Completed | Milan | MI | 20132 | Italy |
| Centre Hospitalier Princesse Grace | Completed | Monaco | 98000 | Monaco |