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

April 17, 2013 updated by: Boston Scientific Corporation

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1060

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298-0053
        • Medical College of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Echo optimized AV delay
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.
Active Comparator: Algorithm optimized AV delay
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.
Active Comparator: Fixed AV Delay
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular End-systolic Volume (LVESV)
Time Frame: 6 months
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary Endpoints Will Include Structural and Functional Measures
Time Frame: Chronic
Chronic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: CRM Clinical Affairs, Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-CA-050508-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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