QuickFlex Micro Left Ventricular Lead Post Approval Study

The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Associates P.C., Birmingham, Alabama, United States

About this study

The primary endpoints of the study are:

Freedom from LV lead-related complications at 5 years
LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study
Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion criteria

Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
Have a life expectancy of less than 5 years due to any condition
Be less than 18 years of age

Treatment and study plan

Implantation of a QuickFlex® μ Model 1258T LV Lead

Device

Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead

Other names: LV pacing lead

Primary outcomes

Percent of Participants Alive and Without a Left Ventricular Lead-related Complication

Time frame: 5 years

Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).
Left Ventricular Bipolar Pacing Capture Threshold

Time frame: 5 years

Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study

Important dates

Study start: 2010
Primary completion: 2017
Study completion: 2017
First posted: Aug 11, 2010
Registry last updated: Aug 12, 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