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

This trial does not accept healthy volunteers

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 population

Patients scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Rhythmia Mapping System
Device
The Rhythmia Mapping System is a 3D electro-anatomical mapping system.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: All Subjects1 intervention

Trial outcomes

Primary outcomes

Physician Feedback on Software Performance

Time frame

1 day- Procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Scientific Corporation

Lead sponsor

Source ClinicalTrials.gov

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