ConsultaTM CRT-D Clinical Evaluation Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device

Conditions
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Tachyarrhythmias, Heart Failure, Ventricular Dysfunction

Intervention / Treatment
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* Device: Bi-ventricular Implantable Cardioverter Defibrillator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantation of Consulta CRT-D<br>Patients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator | Device: Bi-ventricular Implantable Cardioverter Defibrillator<br>* Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator<br>* Other names: ConsultaTM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of Adverse Events reported in the implanted subjects. | 1 month | 
| System Performance Assessed by Holter Records | 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. | 1 month follow-up | 
| System Performance Assessed by Save to Disk Files | 94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias. | 1 month follow-up | 
| System Performance Assessed by Technical Observations | Reported technical observations will be reviewed to determine if there are any device performance issues. | 1 month follow-up |