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The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Birmingham, Alabama, United States
Anchorage, Alaska, United States
Gilbert, Arizona, United States
Scottsdale, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Chula Vista, California, United States
Rancho Mirage, California, United States
Salinas, California, United States
Start Date
January 1, 2012
Primary Completion Date
March 1, 2019
Completion Date
March 1, 2019
Last Updated
March 20, 2019
1,778
ACTUAL participants
Lead Sponsor
Medtronic
NCT07438938
NCT07372196
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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