RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
- Conditions
- Cardiac Arrythmias
- Registration Number
- NCT03053141
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br> 1. Age 18 or above, or above legal age and willing and capable of giving informed<br> consent specific to national law<br><br> 2. Scheduled for standard of care catheter-based endocardial mapping for atrial or<br> ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.<br><br>Exclusion Criteria:<br><br> 1. Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia<br><br> 2. Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia,<br> allergy, etc.)<br><br> 3. Prosthetic or stenotic valves in the chamber where the intended mapping will occur,<br> or in the path of the catheter access route<br><br> 4. Active systemic infection or sepsis<br><br> 5. Hemodynamic instability or shock at baseline precluding ablation in the assessment<br> of the investigator.<br><br> 6. Presence of intracardiac thrombus, tumor, or other abnormality which precludes<br> catheter introduction<br><br> 7. Women who are pregnant or lactating<br><br> 8. Cardiac surgery within the past 90 days<br><br> 9. Acute myocardial infarction within 3 months<br><br> 10. Stable/unstable angina or ongoing myocardial ischemia<br><br> 11. Subjects with an active heart failure decompensation<br><br> 12. Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes<br><br> 13. Congenital heart disease with or without corrective surgery that would complicate a<br> mapping procedure<br><br> 14. Subjects having untreatable allergy to contrast media<br><br> 15. Vascular pathology or tortuosity precluding standard vascular access techniques<br><br> 16. Subjects who are currently enrolled in another investigational study or registry<br> that would directly interfere with the current study, except when the patient is<br> participating in a mandatory governmental registry, or a purely observational<br> registry with no associated treatments. Each instance should be brought to the<br> attention of the sponsor to determine eligibility.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physician Feedback on Software Performance
- Secondary Outcome Measures
Name Time Method