DF4 Connector System Post-Approval Study

Medtronic1,778 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,778

Conditions

Ventricular Tachycardia Ventricular Fibrillation Sudden Cardiac Death Heart Failure

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (78)

Outcomes

Primary Outcomes

DF4 Lead Related Complication Rate

To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead

Time frame: Up to 5 Years

Secondary Outcomes

Types of DF4 lead related events

Number of DF4 lead related events grouped by type

Time frame: Up to 5 years

Bipolar pacing impedance (ohms)

Summary statistics at 5 years post-implant will be reported.

Time frame: 5 years

High voltage impedance (ohms)

Summary statistics at 5 years post-implant will be reported

Time frame: 5 years

Pacing threshold (volts)

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.

Time frame: 5 years

Sensing amplitude (millivolts)

The amplitude of the intrinsic cardiac electrical signals detected by electrodes on the defibrillator lead will be summarized at 5 years post-implant.

Time frame: 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Unnamed facility

Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Gilbert, Arizona, United States

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Scottsdale, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Chula Vista, California, United States

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Rancho Mirage, California, United States

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Salinas, California, United States

...and 68 more locations