Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
- Conditions
- Heart Failure
- Registration Number
- NCT00990665
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Freedom From Left Ventricular Lead-Related Complications Through 3 Months 3 months The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
Freedom From System-related Complications Through 3 Months 3 Months The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. 3 Months The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of \<2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
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
🇺🇸Saint Petersburg, Florida, United States
Scroll for more (14 remaining)University Hospital of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States