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Strategic Management to Optimize Response To Cardiac Resynchronization Therapy (SMART CRT)

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ClinicalTrials.gov Identifier: NCT03089281
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE March 19, 2017
First Posted Date  ICMJE March 24, 2017
Last Update Posted Date March 12, 2021
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
CRT Response [ Time Frame: Pre-Implant baseline to 6 months ]
Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. CRT response is defined by a decrease in Left Ventricular End Systolic Volume (LVESV) ≥ 15% at 6 months compared to pre-implant baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2017)
CRT Response [ Time Frame: 6 months ]
Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. CRT response is defined by a decrease in Left Ventricular End Systolic Volume (LVESV) ≥ 15% at 6 months compared to pre-implant baseline.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
Official Title  ICMJE Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
Brief Summary The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: CRT-D
Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing.
Study Arms  ICMJE
  • SmartDelay™ algorithm
    For those subjects implanted with a Boston Scientific CRT-D identified with an RV-LV ≥70ms, 1:1 randomization will occur via the electronic data capture (EDC) system. Subjects will be randomized to have either an AV Delay and pacing chamber determined by SmartDelay or a Fixed AV Delay of 120ms with BiV pacing.
    Intervention: Device: CRT-D
  • Fixed AV Delay with BiV pacing
    For those subjects implanted with a Boston Scientific CRT-D identified with an RV-LV ≥70ms, 1:1 randomization will occur via the electronic data capture (EDC) system. Subjects will be randomized to have either an AV Delay and pacing chamber determined by SmartDelay or a Fixed AV Delay of 120ms with BiV pacing.
    Intervention: Device: CRT-D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2020)
699
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2017)
726
Actual Study Completion Date  ICMJE September 15, 2020
Actual Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
  • In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:

    • Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
    • Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
  • Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
  • Subject is willing and capable of providing informed consent
  • Subject is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

  • Subjects with documented permanent complete AV block
  • Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
  • Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
  • Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
  • Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
  • Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
  • Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
  • Women of childbearing potential who are or plan to become pregnant during the course of the trial
  • Subjects currently requiring dialysis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Ireland,   Italy,   Japan,   Netherlands,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03089281
Other Study ID Numbers  ICMJE C2067
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael R. Gold, MD Medical University of South Carolina
PRS Account Boston Scientific Corporation
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP