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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.
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 Outcome Measures :
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.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients intended to be implanted or are within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead. All subjects must meet Inclusion criteria and none of the Exclusion 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
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