DF4 Connector System Post-Approval Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01638897

Enrollment

1778

Registered

2012-07-12

Start date

2012-01-31

Completion date

2019-03-31

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia

Keywords

ICD, CRTD, DF4

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada, France, United States

Outcome results