ClinicalTrials.gg
RecruitingNCT03053141RHAPSODYUpdated Oct 23, 2026

RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

An observational study in Cardiac Arrythmias, sponsored by Boston Scientific Corporation. Recruiting at 8 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Boston Scientific Corporation · Observational

From the registry’s dates

  • Started May 2016; still recruiting 10 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

The Rhythmia Mapping System is designed for electroanatomical mapping in catheter ablation procedures by optimizing the need for speed and accuracy. The system is able to simultaneously acquire data from multiple electrodes. In addition, based on user-defined criteria, the system is able to efficiently acquire data over multiple cardiac beats. When used in conjunction with the Rhythmia Mapping Catheter, the system is able to acquire up to hundreds of points per minute leading to fast and detailed map creation.

Since its market release, physicians and users have gained experience with the Boston Scientific Rhythmia Mapping System in the human clinical setting. Improvements to the first generation system are in development and include new and improved software features and mapping algorithms to enhance the clinical operation. These new and improved software features and algorithms require leveraging clinical use data as part of the development and iteration process.

This study will evaluate the performance of potential next-generation software features in a low-risk clinical environment by streaming raw signals from a commercial Rhythmia Workstation during standard of care cardiac mapping and ablation treatments for tachyarrhythmias, specifically atrial fibrillation, atrial tachycardias, and ventricular tachycardia. The data will be evaluated on a parallel investigational Rhythmia Workstation using prototype software features. These next-generation software features and algorithms will not be available to the physician during the case and will therefore have no diagnostic or therapeutic impact on the clinical case.

02

Conditions studied

  • Cardiac Arrythmias
03

In context

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 or above, or above legal age and willing and capable of giving 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

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 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • All Subjects

    All subjects are included in this cohort and are treated with the Rhythmia Mapping System

    Device: Rhythmia Mapping System

Interventions

  • DeviceRhythmia Mapping System

    The Rhythmia Mapping System is a 3D electro-anatomical mapping system.

06

What researchers measure

Primary outcomes

  1. Physician Feedback on Software Performance

    Physician Feedback on Software Performance

    Time frame: 1 day- Procedure

07

Study locations

1 of 8 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT03053141
Responsible party
Sponsor
First posted
Feb 14, 2017
Start date
May 2016
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Susan Hampson
Contact
Susan.Hampson@bsci.com
5087285165
Thomas H McElderry, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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