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)
Southwest EP Clinic
🇺🇸Gilbert, Arizona, United States
Saint Vincent Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Eisenhower Desert Cardiology Center
🇺🇸Rancho Mirage, California, United States
COR Healthcare
🇺🇸Torrance, California, United States
Cardiovascular Consultants Medical Group
🇺🇸Van Nuys, California, United States
Colorado Heart and Vascular, PC
🇺🇸Lakewood, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
MedStar Southern Maryland Hospital Center
🇺🇸Washington, District of Columbia, United States
Bradenton Cardiology
🇺🇸Bradenton, Florida, United States
Baptist Heart Specialists
🇺🇸Jacksonville, Florida, United States
Scroll for more (40 remaining)Southwest EP Clinic🇺🇸Gilbert, Arizona, United States