RecruitingNot Applicable

RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

United States100 participantsStarted 2016-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Physician Feedback on Software Performance

Timeframe: 1 day- Procedure

Trial details

NCT IDNCT03053141

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Susan Hampson

5087285165 Susan.Hampson@bsci.com

View on ClinicalTrials.gov More Cardiac Arrythmias trials