Actively Recruiting
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
Led by Boston Scientific Corporation · Updated on 2026-05-04
100
Participants Needed
8
Research Sites
552 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
- Scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.
You will not qualify if you...
- Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia
- Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia, allergy, etc.)
- Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route
- Active systemic infection or sepsis
- Hemodynamic instability or shock at baseline precluding ablation in the assessment of the investigator.
- Presence of intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
- Women who are pregnant or lactating
- Cardiac surgery within the past 90 days
- Acute myocardial infarction within 3 months
- Stable/unstable angina or ongoing myocardial ischemia
- Subjects with an active heart failure decompensation
- Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
- Congenital heart disease with or without corrective surgery that would complicate a mapping procedure
- Subjects having untreatable allergy to contrast media
- Vascular pathology or tortuosity precluding standard vascular access techniques
- 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.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Completed
2
St. Lukes Idaho Cardiology Associates
Boise, Idaho, United States, 83712
Completed
3
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Completed
4
Cardiovascular Specialists of New England Research Foundation
Londonderry, New Hampshire, United States, 03053
Actively Recruiting
5
Catholic Medical Center
Manchester, New Hampshire, United States, 03102
Completed
6
Valley Hospital
Ridgewood, New Jersey, United States, 07450-2736
Completed
7
Fondazione Centro San Raffaele
Milan, MI, Italy, 20132
Completed
8
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000
Active, Not Recruiting
Research Team
S
Susan Hampson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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