RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
ConditionCardiac Arrythmias
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rhythmia Mapping System
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
8Italy
Fondazione Centro San Raffaele20132, MilanMI, Italy
Monaco
Centre Hospitalier Princesse Grace98000, Monaco Monaco
United States
University of Alabama at Birmingham35233, BirminghamAlabama, United States
St. Lukes Idaho Cardiology Associates83712, BoiseIdaho, United States
Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor
Source ClinicalTrials.gov