RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

Description

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 Overview

Study Details

Study overview

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.

RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

Condition
Cardiac Arrythmias
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Boise

St. Lukes Idaho Cardiology Associates, Boise, Idaho, United States, 83712

Burlington

Lahey Clinic, Inc., Burlington, Massachusetts, United States, 01805

Manchester

Catholic Medical Center, Manchester, New Hampshire, United States, 03102

Ridgewood

Valley Hospital, Ridgewood, New Jersey, United States, 07450-2736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Scientific Corporation,

Thomas H McElderry, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2025-03