DF4 Connector System Post-Approval Study

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Sex eligibility

All sexes

Study type

Observational

Primary location

Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

DF4 Lead Related Complication Rate

Time frame: 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 outcomes

Types of DF4 lead related events

Time frame: Up to 5 years

Number of DF4 lead related events grouped by type
Bipolar pacing impedance (ohms)

Time frame: 5 years

Summary statistics at 5 years post-implant will be reported.
High voltage impedance (ohms)

Time frame: 5 years

Summary statistics at 5 years post-implant will be reported
Pacing threshold (volts)

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2019
Study completion: 2019
First posted: Jul 12, 2012
Registry last updated: Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed