Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||QuickFlex Micro Model 1258T Left Heart Pacing Lead|
- Freedom From Left Ventricular Lead-related Complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.
- Percentage of Successful Left Ventricular Lead Implants [ Time Frame: 3 months ] [ Designated as safety issue: No ]Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.
- Left Ventricular Bipolar Pacing Capture Threshold (Volts) [ Time Frame: 3 months ] [ Designated as safety issue: No ]The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.
|Study Start Date:||October 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Experimental: QuickFlex micro 1258T left heart lead||
Device: QuickFlex Micro Model 1258T Left Heart Lead
Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.
Other Name: Model 1258T left heart pacing lead
The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.
Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.
|United States, Alabama|
|University Hospital-University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, Arkansas|
|Little Rock, Arkansas, United States, 72205|
|Arkansas Heart Hospital|
|Little Rock, Arkansas, United States, 72211|
|United States, California|
|Glendale Memorial Hospital and Medical Center|
|Glendale, California, United States, 91204|
|Regional Cardiology Associates|
|Sacramento, California, United States, 95819|
|United States, Illinois|
|Midwest Heart Foundation|
|Lombard, Illinois, United States, 60148|
|United States, Kentucky|
|Central Baptist Hospital|
|Lexington, Kentucky, United States, 40503|
|United States, Michigan|
|St. John Hospital and Medical Center|
|Detroit, Michigan, United States, 48236|
|Thoracic Cardiovascular Healthcare Foundation|
|Lansing, Michigan, United States, 48910|
|United States, New Jersey|
|Deborah Heart and Lung Center|
|Browns Mills, New Jersey, United States, 08015|
|United States, New York|
|St. Francis Hospital|
|Roslyn, New York, United States, 11576|
|United States, Ohio|
|EMH Regional Medical Center|
|Elyria, Ohio, United States, 44035|
|United States, Tennessee|
|St. Thomas Hospital|
|Nashville, Tennessee, United States, 37205|
|Study Director:||Tamara Shipman||St. Jude Medical|