Evaluating new software features for cardiac mapping

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RHAPSODY study aims to assess the performance of innovative software features in patients undergoing standard catheter-based endocardial mapping for tachyarrhythmias using the Rhythmia Mapping System. This observational study will stream raw signals during mapping and ablation procedures to evaluate the effectiveness of next-generation software in a clinical setting. The data collected will inform the development and refinement of these software features for future commercial use, enhancing the accuracy and speed of cardiac mapping.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cardiovascular Specialists of New England Research Foundation
  Londonderry, New Hampshire, United States Recruiting
• University of Alabama at Birmingham
  Birmingham, Alabama, United States Completed
• St. Lukes Idaho Cardiology Associates
  Boise, Idaho, United States Completed
• Lahey Clinic, Inc.
  Burlington, Massachusetts, United States Completed
• Catholic Medical Center
  Manchester, New Hampshire, United States Completed
• Valley Hospital
  Ridgewood, New Jersey, United States Completed

Study contacts

• Principal investigator: Thomas H McElderry, MD — University of Alabama at Birmingham
• Study coordinator: Susan Hampson
• Email: Susan.Hampson@bsci.com
• Phone: 5087285165

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.