RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
- Cardiac Arrythmias
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Boston Scientific Corporation
- Enrolment target
- 100
- Started
- May 2016
- Main results due
- December 2027
- Study sites
- 8
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(8)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Completed
St. Lukes Idaho Cardiology Associates
Boise, Idaho, United States
Completed
Lahey Clinic, Inc.
Burlington, Massachusetts, United States
Completed
Cardiovascular Specialists of New England Research Foundation
Londonderry, New Hampshire, United States
Recruiting
Catholic Medical Center
Manchester, New Hampshire, United States
Completed
Valley Hospital
Ridgewood, New Jersey, United States
Completed
Fondazione Centro San Raffaele
Milan, MI, Italy
Completed
Centre Hospitalier Princesse Grace
Monaco, Monaco
Completed
Showing 8 of 8 sites. 1 of the 8 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT03053141. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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