Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)

Completed · Phase 4

Conditions studied: Heart Failure

In brief

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 timing chronically over a 6-month period.

Key facts

Study ID

NCT00677014

Run by

Boston Scientific Corporation

People needed

1060

Starts

2008-05-01

Expected to finish

2010-07-01

Last updated by the study team

2013-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical College of Virginia — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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