CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,060 enrolled
Drug / intervention
AV Delay programming through cardiac resynchronization therapy +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00677014
NCT00677014Phase 4Completed
CompareCT.gov

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

Boston Scientific Corporation·interventional·Posted May 13, 2008·Updated Apr 24, 2013

In Brief

A Phase 4 clinical trial evaluating AV Delay programming through cardiac resynchronization therapy for Heart Failure. Completed, enrolled 1,060 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 13, 2008
Enrollment StartMay 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.1 years ago

Interventions

AV Delay programming through cardiac resynchronization therapydevice

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.

AV Delay programming through cardiac resynchronization therapydevice

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.

AV Delay programming through cardiac resynchronization therapydevice

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.