RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Physician Feedback on Software Performance [Срок оценки: 1 day- Procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 6 центров

• University of Alabama at Birmingham — Birmingham
• St. Lukes Idaho Cardiology Associates — Boise
• Lahey Clinic, Inc. — Burlington
• Cardiovascular Specialists of New England Research Foundation — Londonderry
• Catholic Medical Center — Manchester
• Valley Hospital — Ridgewood

Италия · 1 центр

• Fondazione Centro San Raffaele — Milan

Monaco · 1 центр

• Centre Hospitalier Princesse Grace — Monaco

Идентификаторы

NCT: NCT03053141 · 91087667

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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