RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

Recruiting now

Conditions studied: Cardiac Arrythmias

In brief

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.

Key facts

Study ID

NCT03053141

Run by

Boston Scientific Corporation

People needed

100

Starts

2016-05-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
• Scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.

You may not qualify if…

• Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia
• Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia, allergy, etc.)
• Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route
• Active systemic infection or sepsis
• Hemodynamic instability or shock at baseline precluding ablation in the assessment of the investigator.
• Presence of intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
• Women who are pregnant or lactating
• Cardiac surgery within the past 90 days
• Acute myocardial infarction within 3 months
• Stable/unstable angina or ongoing myocardial ischemia
• Subjects with an active heart failure decompensation
• Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
• Congenital heart disease with or without corrective surgery that would complicate a mapping procedure
• Subjects having untreatable allergy to contrast media
• Vascular pathology or tortuosity precluding standard vascular access techniques
• 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 is running

• Cardiovascular Specialists of New England Research Foundation — Londonderry, New Hampshire, United States (enrolling)
• St. Lukes Idaho Cardiology Associates — Boise, Idaho, United States
• Lahey Clinic, Inc. — Burlington, Massachusetts, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Valley Hospital — Ridgewood, New Jersey, United States
• Fondazione Centro San Raffaele — Milan, MI, Italy
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Centre Hospitalier Princesse Grace — Monaco, Monaco

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.