ConsultaTM CRT-D Clinical Evaluation Study
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|ClinicalTrials.gov Identifier: NCT00526162|
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 10, 2009
Last Update Posted : June 10, 2009
|Condition or disease||Intervention/treatment||Phase|
|Tachyarrhythmias Heart Failure Ventricular Dysfunction||Device: Bi-ventricular Implantable Cardioverter Defibrillator||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||October 2008|
Device: Bi-ventricular Implantable Cardioverter Defibrillator
Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator
Other Name: ConsultaTM
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526162
|Study Chair:||Consulta Clinical Study Team||Medtronic Bakken Research Center|