Rhythmia mapping en signaalacquisitie voor data-analyse (RHAPSODY) (RHAPSODY)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Susan Hampson
- Telefoonnummer: 5087285165
- E-mail: Susan.Hampson@bsci.com
Studie Locaties
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MI
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Milan, MI, Italië, 20132
- Voltooid
- Fondazione Centro San Raffaele
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Monaco, Monaco, 98000
- Voltooid
- Centre Hospitalier Princesse Grace
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- Voltooid
- University of Alabama at Birmingham
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Idaho
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Boise, Idaho, Verenigde Staten, 83712
- Voltooid
- St. Lukes Idaho Cardiology Associates
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Massachusetts
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Burlington, Massachusetts, Verenigde Staten, 01805
- Voltooid
- Lahey Clinic, Inc.
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New Hampshire
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Londonderry, New Hampshire, Verenigde Staten, 03053
- Werving
- Cardiovascular Specialists of New England Research Foundation
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Contact:
- Jennifer Driscoll, RN, BSN
- E-mail: jennifer.driscoll@csofne.com
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Hoofdonderzoeker:
- Jamie Kim, MD
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Manchester, New Hampshire, Verenigde Staten, 03102
- Voltooid
- Catholic Medical Center
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New Jersey
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Ridgewood, New Jersey, Verenigde Staten, 07450-2736
- Voltooid
- Valley Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Patients scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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All Subjects
All subjects are included in this cohort and are treated with the Rhythmia Mapping System |
The Rhythmia Mapping System is a 3D electro-anatomical mapping system. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Physician Feedback on Software Performance
Tijdsspanne: 1 day- Procedure
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Physician Feedback on Software Performance |
1 day- Procedure
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Thomas H McElderry, MD, University of Alabama at Birmingham
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 91087667
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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