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Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918) (SMARTMSP)

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: NCT03257436
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Condition or disease Intervention/treatment Phase
Left Ventricular Dysfunction Device: CRT-D Not Applicable

Detailed Description:
Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 586 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : November 19, 2020
Actual Study Completion Date : November 19, 2020
Arms and Interventions
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Arm Intervention/treatment
Single Arm
General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
 Device: CRT-D
Left Ventricular MultiSite Pacing


Outcome Measures
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Primary Outcome Measures :
  1. LV MSP feature [ Time Frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration. ]
    Related complication-free rate.


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  1. Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
  2. Subjects must meet BSC labeled indication for CRT-D implantation.
  3. Subjects must have a functional RA lead and RV lead implanted
  4. Subjects who are willing and capable of providing informed consent
  5. Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
  6. Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

  1. Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
  2. Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
  3. Subjects with documented history of permanent AF
  4. Subjects with documented permanent complete AV block
  5. Subjects who are expected to receive a heart transplant during the 12 months course of the study
  6. Subjects with documented life expectancy of less than 12 months
  7. Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC
Contacts and Locations
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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): NCT03257436


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Saba Samir University of Pittsburgh Medical Center
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03257436    
Other Study ID Numbers: 92050975
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Boston Scientific Corporation:
Pacing
Additional relevant MeSH terms:
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Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases