NCT03053141

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started May 2016

Longer than P75 for all trials

Geographic Reach
3 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2016Dec 2026

Study Start

First participant enrolled

May 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

10.6 years

First QC Date

May 24, 2016

Last Update Submit

May 1, 2026

Conditions

Cardiac Arrythmias

Outcome Measures

Primary Outcomes (1)

  • Physician Feedback on Software Performance

    Physician Feedback on Software Performance

    1 day- Procedure

Study Arms (1)

All Subjects

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

Device: Rhythmia Mapping System

Interventions

Rhythmia Mapping SystemDEVICE

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

All Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

COMPLETED

St. Lukes Idaho Cardiology Associates

Boise, Idaho, 83712, United States

COMPLETED

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

COMPLETED

Cardiovascular Specialists of New England Research Foundation

Londonderry, New Hampshire, 03053, United States

RECRUITING

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

COMPLETED

Valley Hospital

Ridgewood, New Jersey, 07450-2736, United States

COMPLETED

Fondazione Centro San Raffaele

Milan, MI, 20132, Italy

COMPLETED

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

ACTIVE NOT RECRUITING

Study Officials

  • Thomas H McElderry, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Hampson

CONTACT

5087285165Susan.Hampson@bsci.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

February 14, 2017

Study Start

May 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

MO(1)US(6)IT(1)