Overview

This trial is active, not recruiting.

Conditions ventricular tachycardia, ventricular fibrillation, sudden cardiac death, heart failure
Sponsor Medtronic
Start date January 2012
End date January 2019
Trial size 1778 participants
Trial identifier NCT01638897, DF4

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
DF4 Lead Related Complication Rate
time frame: Up to 5 Years

Secondary Outcomes

Measure
Types of DF4 lead related events
time frame: Up to 5 years
Bipolar pacing impedance (ohms)
time frame: 5 years
High voltage impedance (ohms)
time frame: 5 years
Pacing threshold (volts)
time frame: 5 years
Sensing amplitude (millivolts)
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title DF4 Connector System Post-Approval Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medtronic.