Model 4396 Left Ventricular (LV) Lead Chronic Performance Study
- Conditions
- Heart Failure
- Registration Number
- NCT01361685
- Lead Sponsor
- Medtronic
- Brief Summary
Lead survivability will be summarized.
- Detailed Description
The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 366
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Model 4396 LV Lead-related complication rate 5 years
- Secondary Outcome Measures
Name Time Method Bipolar pacing impedance 1 year Bipolar pacing capture threshold 1 year Number of fractures with and without loss of function 5 years Types of lead-related adverse device effects 5 years Bipolar electrical performance at 1 year 1 year Percent of subjects with changes in electrode programming 5 years
Trial Locations
- Locations (50)
MedStar Southern Maryland Hospital Center
🇺🇸Washington, District of Columbia, United States
Cenla Heart Specialists
🇺🇸Alexandria, Louisiana, United States
Our Lady of the Lake Office of Research
🇺🇸Baton Rouge, Louisiana, United States
Wellmont CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
The Christ Hospital Health Network
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Saint Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Aurora Cardiovascular Services
🇺🇸Milwaukee, Wisconsin, United States
Southwest EP Clinic
🇺🇸Gilbert, Arizona, United States
Eisenhower Desert Cardiology Center
🇺🇸Rancho Mirage, California, United States
Cardiovascular Consultants Medical Group
🇺🇸Van Nuys, California, United States
COR Healthcare
🇺🇸Torrance, California, United States
Colorado Heart and Vascular, PC
🇺🇸Lakewood, Colorado, United States
Bradenton Cardiology
🇺🇸Bradenton, Florida, United States
Baptist Heart Specialists
🇺🇸Jacksonville, Florida, United States
Indiana University Health - Methodist Research Institute
🇺🇸Indianapolis, Indiana, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Louisville Cardiology Group
🇺🇸Louisville, Kentucky, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Metropolitan Cardiology Consultants PA
🇺🇸Coon Rapids, Minnesota, United States
Saint Lukes Health System
🇺🇸Kansas City, Missouri, United States
North Memorial Heart and Vascular Institute
🇺🇸Robbinsdale, Minnesota, United States
HealthCare Partners Medical Group
🇺🇸Saint Louis Park, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Patients First Health Care LLC
🇺🇸Washington, Missouri, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
New Jersey Cardiology Associates
🇺🇸West Orange, New Jersey, United States
Central New York Cardiology
🇺🇸Utica, New York, United States
New York-Presbyterian Hospital/Columbia University Medical Center
🇺🇸New York, New York, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
🇺🇸New York, New York, United States
Presbyterian Heart Group
🇺🇸Albuquerque, New Mexico, United States
Medicor Associates
🇺🇸Erie, Pennsylvania, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
WakeMed Health & Hospitals
🇺🇸Raleigh, North Carolina, United States
Lehigh Valley Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
STAR Clinical Trials
🇺🇸San Antonio, Texas, United States
Baylor Research Institute
🇺🇸Plano, Texas, United States
EP Heart LLC
🇺🇸The Woodlands, Texas, United States
The University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Queen's University & Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
🇨🇦Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) Hopital Hotel-Dieu
🇨🇦Montreal, Quebec, Canada
Universitatsklinikum Ulm
🇩🇪Ulm, Baden-württemberg, Germany
Saint Vincent Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Yale University
🇺🇸New Haven, Connecticut, United States