NCT00677014

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

SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,060 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 timing chronically over a 6-month period.

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-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	AV Delay programming through cardiac resynchronization therapy	All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.
DEVICE	AV Delay programming through cardiac resynchronization therapy	All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.
DEVICE	AV Delay programming through cardiac resynchronization therapy	All subjects in this trial receive the same device. For the purpose of this trial. "intervention" is programming of the atrio-ventricular (AV) delay in the two treatment arms, while the control arm will receive AV delay programming from a Fixed nominal setting. Echo optimized and Algorithm optimized are the treatment arms programmed to receive optimized AV delay settings and will be compared to the Fixed nominal arm.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-05-13
• Last updated: 2013-04-24
• Results posted: 2012-08-30

Locations

1 site across 1 country: United States