DF4 Connector System Post-Approval Study

Completed

Conditions studied: Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure

In brief

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.

Key facts

Study ID

NCT01638897

Run by

Medtronic

People needed

1778

Starts

2012-01-01

Expected to finish

2019-03-01

Last updated by the study team

2019-03-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Subject is intended to be implanted or is within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or defibrillation application

You may not qualify if…

• Subject who is, or will be inaccessible for follow-up at a study site
• Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
• Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable

Where it is running

• Study site — Anchorage, Alaska, United States
• Study site — Gilbert, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Salinas, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Torrance, California, United States
• Study site — Van Nuys, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Albany, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.