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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
586

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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