Status:
COMPLETED
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV ...
Detailed Description
SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-...
Eligibility Criteria
Inclusion
- Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
- Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study
- Patients who are on optimal and stable pharmacologic therapy
- Patients who are expected to be in sinus rhythm at the time of implant
- Patients who have a life expectancy of more than 360 days, per physician's discretion
- Patients who are geographically stable and willing to comply with the required follow-up schedule
- Patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law
Exclusion
- Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days
- Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days
- Patients who have previously received cardiac resynchronization therapy
- Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
- Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
- Patients who are pregnant or planning to become pregnant during the study
- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1060 Patients enrolled
Trial Details
Trial ID
NCT00677014
Start Date
May 1 2008
End Date
July 1 2010
Last Update
April 24 2013
Active Locations (1)
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1
Medical College of Virginia
Richmond, Virginia, United States, 23298-0053