Model 4296 Left Ventricular (LV) Lead Study
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Model 4296 Left Ventricular Lead Study|
- Number of Participants With Left Ventricular (LV)Lead Related Complications [ Time Frame: Implant to one-month post implant ] [ Designated as safety issue: No ]A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.
|Study Start Date:||June 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Model 4296 LV Lead
Device: Pacing Lead (Model 4296 LV Lead)
Implant and follow-up of study device
This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.
|Bad Rothenfelde, Germany|
|Principal Investigator:||M. Biffi, M.D.||Policlinico S. Orsola-Malpighi in Bologna, Italy|