DF4 Connector System Post-Approval Study

Heart Failure Clinical Trial

Official title:

DF4 Connector System Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638897
• Other study ID #: DF4
• Status: Completed
• Start date: January 2012
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1778
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 5 Years
Secondary	Types of DF4 lead related events	Number of DF4 lead related events grouped by type	Up to 5 years
Secondary	Bipolar pacing impedance (ohms)	Summary statistics at 5 years post-implant will be reported.	5 years
Secondary	High voltage impedance (ohms)	Summary statistics at 5 years post-implant will be reported	5 years
Secondary	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.	5 years
Secondary	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.	5 years