ConsultaTM CRT-D Clinical Evaluation Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

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).

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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.

Conditions

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Tachyarrhythmias Heart Failure Ventricular Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implantation of Consulta CRT-D

Patients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator

Group Type EXPERIMENTAL

Bi-ventricular Implantable Cardioverter Defibrillator

Intervention Type DEVICE

Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator

Interventions

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Bi-ventricular Implantable Cardioverter Defibrillator

Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator

Intervention Type DEVICE

Other Intervention Names

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ConsultaTM

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No