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

NCT03257436 | Completed Results DMC FDA Device

• 1 other identifier: 92050975
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 54

Brief Summary

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Conditions

Left Ventricular Dysfunction

Keywords

Pacing

Outcome Measures

Primary Outcomes (2)

• LV MSP Feature Related Complication-Free Rate

  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

  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

Study Arms (1)

Single Arm

OTHER

General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.

Device: CRT-D

Interventions

CRT-D DEVICE

Left Ventricular MultiSite Pacing

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects must meet BSC labeled indication for CRT-D implantation.
• Subjects must have a functional RA lead and RV lead implanted
• Subjects who are willing and capable of providing informed consent
• 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
• Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

You may not qualify if:

• Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
• Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
• Subjects with documented history of permanent AF
• Subjects with documented permanent complete AV block
• Subjects who are expected to receive a heart transplant during the 12 months course of the study
• Subjects with documented life expectancy of less than 12 months
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (54)

Mobile Infirmary Medical Center

Mobile, Alabama, 36604, United States

Location

Phoenix Cardiovascular Group

Phoenix, Arizona, 85006, United States

Location

Cardiology Associates of NEA

Jonesboro, Arkansas, 72401, United States

Location

Foothill Cardiology Medical Group

Arcadia, California, 91007, United States

Location

Chula Vista Cardiac Center

Chula Vista, California, 91910, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Desert Heart Rhythm Consultants

Palm Springs, California, 92262, United States

Location

Cardiology Associates Medical Group

Ventura, California, 93003, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Florida Hospital Waterman

Lake Mary, Florida, 32746, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, 60007, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Parkview Hospital Inc

Fort Wayne, Indiana, 46845, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Norton Heart Specialist

Louisville, Kentucky, 40205, United States

Location

Advanced Cardiovascular Specialists

Shreveport, Louisiana, 71105, United States

Location

MedStar Heart and Vascular Institute

Baltimore, Maryland, 21237, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Ascension St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

St. Mary's of Michigan Research Institute at Covenant Medical Ceter

Saginaw, Michigan, 48601, United States

Location

UMMC- Division of Cardiology

Jackson, Mississippi, 39216, United States

Location

St. Lukes Hospital

Kansas City, Missouri, 64111, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Methodist Physicians Clinic Heart Consultants

Omaha, Nebraska, 68114, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Hackensack University Medical Canter

Hackensack, New Jersey, 07601, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Durham VA medical Center

Durham, North Carolina, 27705, United States

Location

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Trihealth- Good Samaritan & Bethesda North Hospitals

Cincinnati, Ohio, 45220, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

Location

Salem Health

Salem, Oregon, 97301, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

Berk Cardiologists

Wyomissing, Pennsylvania, 19610, United States

Location

AnMed Health Clinical Research

Anderson, South Carolina, 29621, United States

Location

Rapid City Regional Health

Rapid City, South Dakota, 75501, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Heartplace, PA

Bedford, Texas, 76021, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

UT Health

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Carient Heart and Vascular

Manassas, Virginia, 20109, United States

Location

Sentara Norfolk General

Norfolk, Virginia, 23507, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Because the study was not designed to randomize subjects to conventional CRT or LV MSP, the potential incremental benefit of LV MSP cannot be quantified.

Results Point of Contact

• Title: Sharda Mehta
• Organization: BostonScientific

sharda.mehta@bsci.com

6785967330

Study Officials

• Saba Samir

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 22, 2017
• Study Start: January 5, 2018
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: January 3, 2022
• Results First Posted: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (54)