Status:
COMPLETED
'Effect of CRT on Defibrillation Threshold Estimates' Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this prospective study is to evaluate the effect of cardiac resynchronization therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization therapy defibril...
Detailed Description
Cardiac Resynchronization Therapy (CRT) has emerged as a promising therapeutic addition in patients with drug refractory heart failure (HF). Along with providing relief of symptoms of HF, cardiac resy...
Eligibility Criteria
Inclusion
- Patient meets standard indications for a Cardiac Resynchronization Therapy - Defibrillator (CRT-D).
- Patient will be implanted with an FDA approved St Jude Medical (SJM) Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and compatible defibrillation lead system.
- Patient is able to tolerate defibrillation threshold (DFT) testing.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Patient has a life expectancy of greater than 6 months from the time of implant.
- Patient has stable heart failure (HF) medications at least one month prior to enrollment.
Exclusion
- Inability to successfully implant an intravascular lead Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device. (i.e. exclude epicardial leads).
- Patient is getting his Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device replaced.
- Inability to successfully obtain the defibrillation threshold (DFT) at implant.
- Currently participating in a clinical trial that includes an active treatment arm or another data collection registry.
- Recent (within 24 hours) administration of Nesiritide™.
- Patient is on amiodarone (other antiarrhythmic agents known to affect defibrillation thresholds - DFTs) at the time of enrollment.
- Patient is pregnant.
- Patient is less than 18 years old.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00626093
Start Date
January 1 2008
End Date
April 1 2010
Last Update
February 5 2019
Active Locations (2)
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1
Pacific Heart Institute
Santa Monica, California, United States, 90404
2
Penrose Hospital
Colorado Springs, Colorado, United States, 80907