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

December 7, 2021 updated by: Boston Scientific Corporation
Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

586

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Mobile Infirmary Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Cardiovascular Group
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Cardiology Associates of NEA
    • California
      • Arcadia, California, United States, 91007
        • Foothill Cardiology Medical Group
      • Chula Vista, California, United States, 91910
        • Chula Vista Cardiac Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Palm Springs, California, United States, 92262
        • Desert Heart Rhythm Consultants
      • Ventura, California, United States, 93003
        • Cardiology Associates Medical Group
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Delray Medical Center
      • Jacksonville, Florida, United States, 32209
        • Uf Health Jacksonville
      • Lake Mary, Florida, United States, 32746
        • Florida Hospital Waterman
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Hospital Network
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Hospital Inc
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Norton Heart Specialist
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Advanced Cardiovascular Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • MedStar Heart and Vascular Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Ascension St. John Hospital & Medical Center
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Saginaw, Michigan, United States, 48601
        • St. Mary's of Michigan Research Institute at Covenant Medical Ceter
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • UMMC- Division of Cardiology
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Lukes Hospital
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Physicians Clinic Heart Consultants
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Canter
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
      • Raleigh, North Carolina, United States, 27610
        • WakeMed
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Trihealth- Good Samaritan & Bethesda North Hospitals
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
      • Youngstown, Ohio, United States, 44501
        • St. Elizabeth Youngstown Hospital
    • Oregon
      • Salem, Oregon, United States, 97301
        • SALEM Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health Cardiovascular Institute
      • Wyomissing, Pennsylvania, United States, 19610
        • Berk Cardiologists
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Clinical Research
    • South Dakota
      • Rapid City, South Dakota, United States, 75501
        • Rapid City Regional Health
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Stern Cardiovascular Foundation
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Bedford, Texas, United States, 76021
        • Heartplace, PA
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • UT Health
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Manassas, Virginia, United States, 20109
        • Carient Heart and Vascular
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV MSP Feature Related Complication-Free Rate
Time Frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
Proportion of subjects free from LVMSP feature related complications at 12 months
Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
Time Frame: 12 Month Follow Up
Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.
12 Month Follow Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Saba Samir, University of Pittsburgh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2018

Primary Completion (Actual)

November 19, 2020

Study Completion (Actual)

November 19, 2020

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 92050975

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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