Actively Recruiting
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
Led by Boston Scientific Corporation · Updated on 2026-05-27
100
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new software features in the Rhythmia Mapping System used during catheter-based endocardial mapping procedures for patients with atrial or ventricular tachyarrhythmias. This study focuses on assessing how these next-generation software features perform when used alongside the standard Rhythmia Mapping System during cardiac procedures, aiming to help improve future commercial software releases. Participants undergo standard of care catheter-based mapping and ablation for heart rhythm disorders using the commercial Rhythmia Mapping System. During these procedures, raw signal data are streamed to an investigational Rhythmia Workstation running prototype software features for parallel evaluation. These new features do not influence the medical decisions or treatment during the procedure. Participants will be monitored during their catheter mapping procedures, and physician feedback on the software performance will be collected immediately after the procedure. The study involves no additional interventions beyond usual care. Data from these observations will guide software development, with the study period lasting from procedure day through feedback collection.
CONDITIONS
Brief Title
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older or above legal age and able to give informed consent
- Scheduled for catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using the Rhythmia Mapping System
You will not qualify if you...
- Blood clotting or bleeding disorders such as coagulopathy or blood dyscrasia
- Unable to tolerate heparin therapy (e.g., allergy or heparin-induced thrombocytopenia)
- Presence of prosthetic or stenotic valves in the heart chamber to be mapped or catheter path
- Active systemic infection or sepsis
- Hemodynamic instability or shock preventing ablation
- Presence of intracardiac thrombus, tumor, or other abnormalities blocking catheter access
- Pregnant or breastfeeding women
- Cardiac surgery within the past 90 days
- Acute myocardial infarction within past 3 months
- Stable or unstable angina or ongoing myocardial ischemia
- Active heart failure decompensation
- Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
- Complex congenital heart disease complicating mapping
- Untreatable allergy to contrast media
- Vascular disease or tortuosity preventing standard vascular access
- Currently enrolled in another investigational study that interferes with this trial, except mandatory registries or purely observational studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day - Procedure
Participants undergo catheter-based endocardial mapping using the Rhythmia Mapping System during their standard of care cardiac ablation procedure.
1 procedure visit (in-person)
Duration - Up to study completion
Participants are observed for outcomes related to the investigational software features without any change in their standard clinical care.
No additional visits beyond routine clinical follow-up
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
Completed
Research Team
S
Susan Hampson
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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