Status:
TERMINATED
BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure. Additionally in CRT patien...
Detailed Description
* This is a prospective, randomized, and multicenter study * Patients who have received a replacement St. Jude Medical(SJM) CRT device, either CRT-P or CRT-D, within the last two weeks post CRT replac...
Eligibility Criteria
Inclusion
- Patient underwent a CRT replacement within the last two weeks, triggered by either the elective replacement indicator (ERI)/end of life (EOL), or by receiving a CRT-D device as an upgrade from a CRT-P device.
- Patient has received an FDA approved SJM CRT device as a replacement to the old CRT device within the last two weeks.
- Patient has the ability to complete a 6-minute hall walk without any assistance.
- Patient is willing to provide written informed consent.
- Patient has the ability to independently comprehend and complete a QOL questionnaire.
- Patient is geographically stable and is willing to comply with the required follow-up schedule.
Exclusion
- Patient had paced/sensed AV and/or V-V delay optimization using QuickOpt before CRT replacement.
- Patient had any paced/sensed AV and/or V-V delay optimization within 3 months before CRT replacement.
- Patient has an ability to walk ≥ 450 meters (≥ 1476 feet) in 6 minutes.
- Adequate patient's echocardiography/Doppler images will not be available.
- Patient is expected to receive a heart transplant during the duration of the study.
- Patient has an epicardial ventricular lead system (Active or Inactive).
- Patient has limited intrinsic atrial activity (≤ 40 bpm).
- Patient has persistent or permanent atrial fibrillation (AF).
- Patient has 2° or 3° heart block.
- Patient's life expectancy is less than 1 year.
- Patient is less than 18 years old.
- Patient is pregnant.
- Patient is on IV inotropic agents 1 month prior to CRT replacement.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00929474
Start Date
June 1 2009
End Date
September 1 2010
Last Update
February 4 2019
Active Locations (2)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
2
Hattiesburg Clinic, P.A./Southern Heart Center
Hattiesburg, Mississippi, United States, 39401