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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00677014
First received: May 9, 2008
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: AV Delay programming through cardiac resynchronization therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Left Ventricular End-systolic Volume (LVESV) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Chronic ] [ Designated as safety issue: No ]

Enrollment: 1060
Study Start Date: May 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Echo optimized AV delay
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
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677014

Locations
United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States, 23298-0053
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: CRM Clinical Affairs Boston Scientific Corporation
  More Information

Additional Information:
Publications:

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00677014     History of Changes
Other Study ID Numbers: CR-CA-050508-H
Study First Received: May 9, 2008
Results First Received: July 27, 2012
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission
Spain: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Boston Scientific Corporation:
Heart Failure
HF
Cardiac Resynchronization Therapy
CRT
Optimization
SmartDelay
Echocardiography
AV Delay

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014