QuickFlex Micro Left Ventricular Lead Post Approval Study

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: Implantation of a QuickFlex® μ Model 1258T LV Lead

Study type: Observational

Funder types: Industry

Identifiers

NCT01179477

CRD561

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,930 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design