ConsultaTM CRT-D Clinical Evaluation Study

Not Applicable

Completed

Interventions: Device: Bi-ventricular Implantable Cardioverter Defibrillator

Brief Summary: 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).

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Implantation of Consulta CRT-D	Bi-ventricular Implantable Cardioverter Defibrillator	Patients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator

Primary Outcome Measures

Name	Time	Method
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.	1 month	Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 month	Number of Adverse Events reported in the implanted subjects.
System Performance Assessed by Holter Records	1 month follow-up	The first 20 digital Holter records that were successfully collected in the total of 80 implanted subjects were analysed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
System Performance Assessed by Save to Disk Files	1 month follow-up	94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
System Performance Assessed by Technical Observations	1 month follow-up	Reported technical observations will be reviewed to determine if there are any device performance issues.