What this study is
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.
What's being tested
- Rhythmia Mapping System
Intervention · DEVICE
The Rhythmia Mapping System is a 3D electro-anatomical mapping system.
Study details
- Sponsor
- Boston Scientific Corporation
- Conditions
- Cardiac Arrythmias
- Enrolling
- 100 people
- Starts
- 2016-05
- Est. completion
- 2027-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
1 openCardiovascular Specialists of New England Research Foundation
Londonderry, New Hampshire, United States
- Jennifer Driscoll, RN, BSN · Contactjennifer.driscoll@csofne.com
- Jamie Kim, MD · Principal investigator
RecruitingUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
CompletedSt. Lukes Idaho Cardiology Associates
Boise, Idaho, United States
CompletedLahey Clinic, Inc.
Burlington, Massachusetts, United States
CompletedCatholic Medical Center
Manchester, New Hampshire, United States
CompletedValley Hospital
Ridgewood, New Jersey, United States
Completed
2 sites outside the US
Fondazione Centro San Raffaele
Milan, MI, Italy
CompletedCentre Hospitalier Princesse Grace
Monaco, Monaco
Completed
Study team
Sponsor
Boston Scientific Corporation
Study ID 91087667
Principal investigator
Thomas H McElderry, MD
University of Alabama at Birmingham
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.