SMARTDELAY

SMART- AV - SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

Principal Investigator Name: Alan Cheng, M.D.

Study Coordinator Name: Elizabeth Robinson, R.N.

Contact Phone: (410) 502 - 0517
Study Coordinator

Contact E-mail: erobin26@jhmi.edu
Study Coordinator

Study Short Title: SMART-AV

Study Long Title: SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

IRB Number: JH-eIRB #NA_ 00020957

Funding Source: Boston Scientific Corporation

Summary of Trial: To assess the effect of the SmartDelay BSC algorithm for determining optimal AV delay timing during CRT compared to both a fixed nominal AV delay and echocardiography-determined optimal AV timing over a 6 month period. SMART-AV is a randomized, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy.

Inclusions:

• Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
• Patients who are on optimal and stable pharmacologic therapy (see protocol for details)
• Patients who are expected to be in sinus rhythm at the time of implant

Exclusions: Patients 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 have other cardiac surgeries or procedures planned during the course of the study
• Patients who have a condition that prevents normal, unsupported walking

Clinical Trial Site:

Johns Hopkins University
600 N. Wolfe Street, Carnegie 586
Baltimore, MD 21287

Compensation for Participating? No, but parking passes will be distributed to assist with travel expenses.

Start Date: 2008

Anticipated End Date: 2010