ConsultaTM CRT-D Clinical Evaluation Study

Heart Failure Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Tachyarrhythmias
• Tachycardia
• Ventricular Dysfunction

• NCT number: NCT00526162
• Study type: Interventional
• Source: Medtronic Bakken Research Center
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Completion date: October 2008