ConsultaTM CRT-D Clinical Evaluation Study
|Tachyarrhythmias Heart Failure Ventricular Dysfunction||Device: Bi-ventricular Implantable Cardioverter Defibrillator|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device|
- Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant. [ Time Frame: 1 month ]
- Describe System Performance [ Time Frame: 1 month ]
- Adverse Events [ Time Frame: 1 month ]
|Study Start Date:||October 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Device: Bi-ventricular Implantable Cardioverter Defibrillator
Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
Other Name: ConsultaTM
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526162
|Study Chair:||Consulta Clinical Study Team||Medtronic Bakken Research Center|