Quadripolar Pacing Post Approval Study

Completed

Conditions studied: Heart Failure

In brief

The purpose of this post-approval study is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy (CRT).

Key facts

Study ID

NCT01555619

Run by

Abbott Medical Devices

People needed

1971

Starts

2012-02-15

Expected to finish

2019-02-28

Last updated by the study team

2019-04-16

Who can join

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

You may qualify if…

• Approved indication per current American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s).
• Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study (Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing implantable cardioverter-defibrillator or pacemaker implant with no prior LV lead placement.
• 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
• Have a life expectancy of less than 5 years due to any condition
• Be less than 18 years of age

Where it is running

• Heart Center Research, LLC/Research Center — Huntsville, Alabama, United States
• Southeastern Cardiology Consultants PC — Montgomery, Alabama, United States
• Arizona Arrhythmia Research Center — Phoenix, Arizona, United States
• Washington Regional Medical Center — Fayetteville, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Comprehensive Cardiovascular — Bakersfield, California, United States
• Scripps Green Hospital — La Jolla, California, United States
• USC Unversity Hospital — Los Angeles, California, United States
• Fogarty Institute — Mountain View, California, United States
• Premier Cardiology, Inc. — Newport Beach, California, United States
• Cardiac Rhythm Specialists, Inc. — Northridge, California, United States
• St. Joseph Heritage Medical Group — Orange, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• St. Joseph's Medical Center — Stockton, California, United States
• Cardiology Associates Medical Group, Inc. — Ventura, California, United States
• Florida Electrophysiology Associates — Atlantis, Florida, United States
• Yoel R. Vivas, MD — Boynton Beach, Florida, United States
• Jorge Diaz — Lake Mary, Florida, United States
• Naples Heart Rhythm Specialists — Naples, Florida, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• Florida Heart Rhythm Specialists, LLC — Plantation, Florida, United States
• Northside Hospital — St. Petersburg, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Piedmont Heart Institue — Atlanta, Georgia, United States
• Cardiology, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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