Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT) (SMART-AV)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AV Delay programming through cardiac resynchronization therapy
AV Delay programming through cardiac resynchronization therapy
AV Delay programming through cardiac resynchronization therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, HF, Cardiac Resynchronization Therapy, CRT, Optimization, SmartDelay, Echocardiography, AV Delay
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
Sites / Locations
- Medical College of Virginia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Echo optimized AV delay
Algorithm optimized AV delay
Fixed AV Delay
Arm Description
Echo optimized AV delay
Algorithm optimized AV delay
Fixed AV Delay
Outcomes
Primary Outcome Measures
Left Ventricular End-systolic Volume (LVESV)
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
Secondary Outcome Measures
Secondary Endpoints Will Include Structural and Functional Measures
Full Information
NCT ID
NCT00677014
First Posted
May 9, 2008
Last Updated
April 17, 2013
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00677014
Brief Title
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
Acronym
SMART-AV
Official Title
SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, HF, Cardiac Resynchronization Therapy, CRT, Optimization, SmartDelay, Echocardiography, AV Delay
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1060 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Echo optimized AV delay
Arm Type
Active Comparator
Arm Description
Echo optimized AV delay
Arm Title
Algorithm optimized AV delay
Arm Type
Active Comparator
Arm Description
Algorithm optimized AV delay
Arm Title
Fixed AV Delay
Arm Type
Active Comparator
Arm Description
Fixed AV Delay
Intervention Type
Device
Intervention Name(s)
AV Delay programming through cardiac resynchronization therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AV Delay programming through cardiac resynchronization therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AV Delay programming through cardiac resynchronization therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Left Ventricular End-systolic Volume (LVESV)
Description
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary Endpoints Will Include Structural and Functional Measures
Time Frame
Chronic
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CRM Clinical Affairs
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0053
Country
United States
12. IPD Sharing Statement
Citations:
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10368116
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Links:
URL
http://www.bostonscientific.com
Description
Sponsor website
Learn more about this trial
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
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