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Trial record 1 of 1 for:    NCT03089281
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Strategic Management to Optimize Response To Cardiac Resynchronization Therapy (SMART CRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089281
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

Condition or disease Intervention/treatment Phase
Heart Failure Device: CRT-D Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 699 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089281


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Michael R. Gold, MD Medical University of South Carolina

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03089281    
Other Study ID Numbers: C2067
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases