Phase 4 N=980 Randomized Double-blind Treatment

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

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT00677014 ↗

Enrolled (actual)

980

Serious AEs

—

Results posted

Aug 2012

Primary outcome: Primary: Left Ventricular End-systolic Volume (LVESV) — -15; -19; -21 ml — p=.66

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: AV Delay programming through cardiac resynchronization therapy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Left Ventricular End-systolic Volume (LVESV)	-15; -19; -21	.66
SECONDARY Secondary Endpoints Will Include Structural and Functional Measures	—	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00677014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.