Rhythmia Mapping System: The Rhythmia Mapping System is a 3D electro-anatomical mapping system.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 catheter access route
4. Active systemic infection or sepsis
5. Hemodynamic instability or shock at baseline precluding ablation in the assessment of the investigator.
6. Presence of intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
7. Women who are pregnant or lactating
8. Cardiac surgery within the past 90 days
9. Acute myocardial infarction within 3 months
10. Stable/unstable angina or ongoing myocardial ischemia
11. Subjects with an active heart failure decompensation
12. Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
13. Congenital heart disease with or without corrective surgery that would complicate a mapping procedure
14. Subjects having untreatable allergy to contrast media
15. Vascular pathology or tortuosity precluding standard vascular access techniques
16. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
Primary outcome measure(s)
Physician Feedback on Software Performance — 1 day- Procedure Physician Feedback on Software Performance
Trial sites (8)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Completed
St. Lukes Idaho Cardiology Associates
Boise
Idaho
Completed
Lahey Clinic, Inc.
Burlington
Massachusetts
Completed
Cardiovascular Specialists of New England Research Foundation
Londonderry
New Hampshire
Recruiting
Catholic Medical Center
Manchester
New Hampshire
Completed
Valley Hospital
Ridgewood
New Jersey
Completed
Fondazione Centro San Raffaele
Milan
MI
Completed
Centre Hospitalier Princesse Grace
Monaco
Monaco
Completed
More Boston Scientific Corporation trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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