DF4 Connector System Post-Approval Study

Completed

• Conditions: Sudden Cardiac Death; Heart Failure; Ventricular Tachycardia; Ventricular Fibrillation

• Registration Number: NCT01638897
• Lead Sponsor: Medtronic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-12
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1778

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DF4 Lead Related Complication Rate	Up to 5 Years	To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead

Secondary Outcome Measures

Name	Time	Method
Types of DF4 lead related events	Up to 5 years	Number of DF4 lead related events grouped by type
Bipolar pacing impedance (ohms)	5 years	Summary statistics at 5 years post-implant will be reported.
High voltage impedance (ohms)	5 years	Summary statistics at 5 years post-implant will be reported
Pacing threshold (volts)	5 years	The pacing threshold is the minimum electrical stimulus needed to consistently depolarize the heart outside of the heart's refractory period. Summary statistics at 5 years post-implant will be reported.
Sensing amplitude (millivolts)	5 years	The amplitude of the intrinsic cardiac electrical signals detected by electrodes on the defibrillator lead will be summarized at 5 years post-implant.