ConsultaTM CRT-D Clinical Evaluation Study

Medtronic

Status

Completed

Conditions

Ventricular Dysfunction

Heart Failure

Tachyarrhythmias

Treatments

Device: Bi-ventricular Implantable Cardioverter Defibrillator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00526162

112

Details and patient eligibility

About

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).

Full description

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.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.