Status:
COMPLETED
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00990665
Start Date
September 1 2009
End Date
July 1 2012
Last Update
February 27 2019
Active Locations (24)
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1
University Hospital of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Baptist Health Medical Center
Little Rock, Arkansas, United States, 72205
3
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
4
Glendale Memorial Medical Center
Glendale, California, United States, 91204