Evaluating new software features for cardiac mapping

RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

This study tests new software features to see if they can make heart mapping during procedures for fast heart rhythms easier and more accurate for patients.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boston Scientific Corporation (industry)
• Locations: 8 sites (Birmingham, Alabama and 7 other locations)
• Trial ID: NCT03053141 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for catheter-based mapping of atrial or ventricular tachyarrhythmias.

Not a fit: Patients with coagulopathy, active infections, or recent cardiac surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved mapping technologies that enhance the treatment of cardiac arrhythmias.

How similar studies have performed: Other studies have shown promise in improving cardiac mapping technologies, but this specific approach is novel.

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.

Where this trial is running

Birmingham, Alabama and 7 other locations

• 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)
• Cardiovascular Specialists of New England Research Foundation — Londonderry, New Hampshire, United States (RECRUITING)
• Catholic Medical Center — Manchester, New Hampshire, United States (COMPLETED)
• Valley Hospital — Ridgewood, New Jersey, United States (COMPLETED)
• Fondazione Centro San Raffaele — Milan, MI, Italy (COMPLETED)
• Centre Hospitalier Princesse Grace — Monaco, Monaco (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Thomas H McElderry, MD — University of Alabama at Birmingham
• Study coordinator: Susan Hampson

Conditions: Cardiac Arrythmias