Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
- Conditions
- Heart Failure
- Interventions
- Device: QuickFlex Micro Model 1258T Left Heart Lead
- Registration Number
- NCT00763698
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Approved indication for CRT-D system
- Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
- Previous left ventricular (LV) lead implant
- Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description QuickFlex micro 1258T left heart lead QuickFlex Micro Model 1258T Left Heart Lead -
- Primary Outcome Measures
Name Time Method Freedom From Left Ventricular Lead-related Complications 3 months 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 3 months 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) 3 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Arkansas Cardiology
🇺🇸Little Rock, Arkansas, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Thoracic Cardiovascular Healthcare Foundation
🇺🇸Lansing, Michigan, United States
Glendale Memorial Hospital and Medical Center
🇺🇸Glendale, California, United States
Midwest Heart Foundation
🇺🇸Lombard, Illinois, United States
EMH Regional Medical Center
🇺🇸Elyria, Ohio, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
University Hospital-University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Regional Cardiology Associates
🇺🇸Sacramento, California, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States