QuickFlex Micro Left Ventricular Lead Post Approval Study

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01179477

Run by

Abbott Medical Devices

People needed

1930

Starts

2010-09-01

Expected to finish

2017-09-01

Last updated by the study team

2019-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Glendale Memorial Hospital and Medical Center — Glendale, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• University of California at San Diego (UCSD) Medical Center — San Diego, California, United States
• Claudio Bonometti MD, Inc — Santa Barbara, California, United States
• Los Angeles Biomedical Research Institute at Harbor-UCLA — Torrance, California, United States
• Christiana Hospital — Newark, Delaware, United States
• Shands Jacksonville — Jacksonville, Florida, United States
• Naushad Shaik, MD — Kissimmee, Florida, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• Usman R. Siddiqui, MD — Orlando, Florida, United States
• Orlando Heart Center — Orlando, Florida, United States
• Brevard Cardiovascular Research Associates, Inc. — Rockledge, Florida, United States
• University of South Florida, Cardiovascular Services — Tampa, Florida, United States
• Athens Regional Medical Center — Athens, Georgia, United States
• Cardiovascular Associates P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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