ConsultaTM CRT-D Clinical Evaluation Study

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.

Inclusion Criteria:

• Patients who have an indication for a defibrillator.
• Patients who are optimally treated with medication.
• Patients who are New York Heart Association (NYHA) Class III or IV

Exclusion Criteria:

• Patients with a life expectancy less than the duration of the study.
• Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
• Patients with mechanical tricuspid heart valves.