RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
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.
Conditions:
🦠 Cardiac Arrythmias
🗓️ Study Start (Actual) May 2016
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Boise, Idaho, United States
📍 Burlington, Massachusetts, United States
📍 Manchester, New Hampshire, United States
📍 Ridgewood, New Jersey, United States
📍 Milan, MI, Italy
📍 Monaco, Monaco

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 May 2016
  • First Submitted that Met QC Criteria 10 February 2017
  • First Posted 14 February 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 July 2024
  • Last Update Posted 16 July 2024
  • Last Verified July 2024