Heart Failure Clinical Trial
Official title:
Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
The Consulta CRT-D is an investigational bi-ventricular device that provides atrial and
ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation and cardiac
resynchronization therapy.
The study will be a prospective, non-randomized, multicenter clinical study, conducted in
approximately 18 centers.
To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted
with the Consulta device. Data will be collected at baseline (enrollment), implant, 1-, 3-,
and 6- months post implant and every 6 months thereafter or until study closure (whichever
occurs first), unscheduled follow-up visits, System Modifications, Technical Observations,
Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case
of death.
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