Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

Completed · Not applicable

Conditions studied: Heart Failure

In brief

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.

Key facts

Study ID

NCT00990665

Run by

Abbott Medical Devices

People needed

178

Starts

2009-09-01

Expected to finish

2012-07-01

Last updated by the study team

2019-02-27

Who can join

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

You may qualify if…

• Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
• Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
• Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

You may not qualify if…

• Have had a recent CVA or TIA within three months of enrollment
• Have a contraindication for an emergency thoracotomy
• Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
• Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
• Have undergone a cardiac transplantation within 40 days of enrollment
• Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
• Are currently participating in a clinical investigation that includes an active treatment arm
• Are pregnant or planning to become pregnant during the duration of the study
• Have a life expectancy of less than 6 months due to any condition
• Are less than 18 years of age
• Are unable to comply with the follow up schedule

Where it is running

• University Hospital of Alabama at Birmingham — Birmingham, Alabama, United States
• Baptist Health Medical Center — Little Rock, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Glendale Memorial Medical Center — Glendale, California, United States
• University of Southern California — Los Angeles, California, United States
• ACS Research Group — Mountain View, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• Scripps Green Hospital — San Diego, California, United States
• Orlando Heart Center — Orlando, Florida, United States
• The Heart and Vascular Institute of Florida - S. Pinellas — St. Petersburg, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Midwest Heart Foundation — Lombard, Illinois, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• Lahey Clinical Medical Center — Burlington, Massachusetts, United States
• Thoracic Cardiovascular Healthcare Foundation — Lansing, Michigan, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Mount Sinai Hospital — New York, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• EMH Regional Medical Center — Elyria, Ohio, United States
• Lancaster Heart Foundation — Lancaster, Pennsylvania, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• St. Thomas Hospital — Nashville, Tennessee, United States
• Arrhythmia Center for Southern Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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