Recruiting

Observational Study

Sponsor:

Boston Scientific Corporation

Code:

NCT03053141

Conditions

Cardiac Arrythmias

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rhythmia Mapping System

Study Details

Brief 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.

Conditions

Cardiac Arrythmias

Study ID

NCT03053141

Start date

May, 2016

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

All Subjects

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

Interventions

Rhythmia Mapping System

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

Primary outcome measure

  • Physician Feedback on Software Performance [ Time Frame: 1 day- Procedure ]

Central Contacts and Locations

Central contacts

Locations

Cardiovascular Specialists of New England Research Foundation

Recruiting

Londonderry, New Hampshire, United States, 03053

Contacts

Jennifer Driscoll, RN, BSN

jennifer.driscoll@csofne.com

Principal Investigator:

Jamie Kim, MD

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-08-28.