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RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) (RHAPSODY)

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ClinicalTrials.gov Identifier: NCT03053141
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment
Cardiac Arrythmias Device: Rhythmia Mapping System

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.


Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Group/Cohort Intervention/treatment
All Subjects
All subjects are included in this cohort and are treated with the Rhythmia Mapping System
Device: Rhythmia Mapping System
The Rhythmia Mapping System is a 3D electro-anatomical mapping system.




Primary Outcome Measures :
  1. Physician Feedback on Software Performance [ Time Frame: 1 day- Procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053141


Contacts
Contact: Micki Weisman micki.weisman@bsci.com
Contact: Timothy Meyer, PhD timothy.meyer@bsci.com

Locations
United States, Alabama
University of Alabama, Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Alicia Gunter       martina@uab.edu   
Principal Investigator: Thomas H McElderry, MD         
Italy
San Raffaele Hospital Recruiting
Milan, Italy
Contact: Caterina Bisceglia, MD       bisceglia.caterina@hsr.it   
Principal Investigator: Paolo Della Bella, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Thomas H McElderry, MD University of Alabama at Birmingham

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03053141     History of Changes
Other Study ID Numbers: 91087667
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes