NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
| NCT ID | NCT03053141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Cardiac Arrythmias |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2016-05 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2016-05 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law 2. Scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Exclusion Criteria: 1. Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia 2. Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia, allergy, etc.) 3. Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route 4. Active systemic infection or sepsis 5. Hemodynamic instability or shock at baseline precluding ablation in the assessment of the investigator. 6. Presence of intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction 7. Women who are pregnant or lactating 8. Cardiac surgery within the past 90 days 9. Acute myocardial infarction within 3 months 10. Stable/unstable angina or ongoing myocardial ischemia 11. Subjects with an active heart failure decompensation 12. Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes 13. Congenital heart disease with or without corrective surgery that would complicate a mapping procedure 14. Subjects having untreatable allergy to contrast media 15. Vascular pathology or tortuosity precluding standard vascular access techniques 16. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
Contact & Investigator
Thomas H McElderry, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT03053141 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrythmias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03053141 currently recruiting?
Yes, NCT03053141 is actively recruiting participants. Contact the research team at Susan.Hampson@bsci.com for enrollment information.
Where is the NCT03053141 trial being conducted?
This trial is being conducted at Birmingham, United States, Boise, United States, Burlington, United States, Londonderry, United States and 4 additional locations.
Who is sponsoring the NCT03053141 clinical trial?
NCT03053141 is sponsored by Boston Scientific Corporation. The principal investigator is Thomas H McElderry, MD at University of Alabama at Birmingham. The trial plans to enroll 100 participants.