QuickFlex Micro Left Ventricular Lead Post Approval Study

Completed

• Conditions: Heart Failure

• Registration Number: NCT01179477
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-11
• Study Start: 2010-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Results First Submitted: 2018-11-06
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-01
• Last Update Submitted: 2019-07-01
• Results First Posted: 2019-08-12
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1930

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication	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	5 years	Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up

Trial Locations

Locations (77)

Cardiovascular Associates P.C.; 🇺🇸 Birmingham, Alabama, United States

University Hospital - Univ. of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States

Heart Center Research, LLC.; 🇺🇸 Huntsville, Alabama, United States

Alaska Heart Institute; 🇺🇸 Anchorage, Alaska, United States

Arizona Arrhythmia Research Center; 🇺🇸 Phoenix, Arizona, United States

Arizona Arrhythmia Consultants; 🇺🇸 Scottsdale, Arizona, United States

Arkansas Cardiology; 🇺🇸 Little Rock, Arkansas, United States

St. Vincent Heart Clinic Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Northwest Cardiology; 🇺🇸 Springdale, Arkansas, United States

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