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

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Device: AV Delay programming through cardiac resynchronization therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00677014

CR-CA-050508-H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,060 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,060 participants in 3 patient groups

Echo optimized AV delay

Active Comparator group

Description:

Echo optimized AV delay

Treatment:

Device: AV Delay programming through cardiac resynchronization therapy

Device: AV Delay programming through cardiac resynchronization therapy

Device: AV Delay programming through cardiac resynchronization therapy

Algorithm optimized AV delay

Active Comparator group

Description:

Algorithm optimized AV delay

Treatment:

Device: AV Delay programming through cardiac resynchronization therapy

Device: AV Delay programming through cardiac resynchronization therapy

Device: AV Delay programming through cardiac resynchronization therapy

Fixed AV Delay

Active Comparator group

Description:

Fixed AV Delay

Treatment:

Device: AV Delay programming through cardiac resynchronization therapy

Device: AV Delay programming through cardiac resynchronization therapy

Device: AV Delay programming through cardiac resynchronization therapy