MultiPoint Pacing™ Post Market Study

NCT ID: NCT02832622

Last Updated: 2021-02-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-07-15

Brief Summary

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This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.

Detailed Description

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Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MPP Programming

This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.

MPP

Intervention Type DEVICE

MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)

BiV/MPP

Intervention Type DEVICE

MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)

Interventions

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MPP

MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)

Intervention Type DEVICE

BiV/MPP

MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular lead placement
* Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria

* Are expected to receive a heart transplant during the duration of the study
* Have an epicardial ventricular lead system (Active or Inactive)
* Are less than 18 years of age
* Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm
* Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clay Cohorn

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

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University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Site Status

Heart Center Research, LLC.

Huntsville, Alabama, United States

Site Status

Integrated Medical Services

Avondale, Arizona, United States

Site Status

Cardiovascular Consultants Ltd

Glendale, Arizona, United States

Site Status

Arizona Arrhythmia Research Center

Phoenix, Arizona, United States

Site Status

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

Site Status

John C. Lincoln North Mountain Hospital

Phoenix, Arizona, United States

Site Status

Arizona Arrhythmia Consultants

Scottsdale, Arizona, United States

Site Status

Comprehensive Cardiovascular Specialists

Alhambra, California, United States

Site Status

USC University Hospital

Los Angeles, California, United States

Site Status

Jeffrey Goodman

Los Angeles, California, United States

Site Status

Premier Cardiology, Inc

Newport Beach, California, United States

Site Status

Desert Heart Rhythm Consultants

Palm Springs, California, United States

Site Status

Chaparral Medical Group

Pomona, California, United States

Site Status

Cardiac Rhythm Specialists, Inc.

Reseda, California, United States

Site Status

San Diego Cardiac Center

San Diego, California, United States

Site Status

COR Healthcare Medical Associates

Torrance, California, United States

Site Status

Aurora Denver Cardiology Associates, P.C.

Aurora, Colorado, United States

Site Status

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, United States

Site Status

Cardiac Arrhythmia Services

Boca Raton, Florida, United States

Site Status

Yoel R. Vivas, MD

Delray Beach, Florida, United States

Site Status

Heart Rhythm Solutions

Hollywood, Florida, United States

Site Status

Citrus Cardiology Consultants, PA

Inverness, Florida, United States

Site Status

St. Vincent's Medical Center

Jacksonville, Florida, United States

Site Status

Naushad Shaik, MD

Kissimmee, Florida, United States

Site Status

Jorge Diaz, M.D., P.A.

Lake Mary, Florida, United States

Site Status

Central Florida Medical Research

New Smyrna Beach, Florida, United States

Site Status

Usman R. Siddiqui, MD

Orlando, Florida, United States

Site Status

Sacred Heart Hospital

Pensacola, Florida, United States

Site Status

Brevard Cardiovascular Research Associates, Inc.

Rockledge, Florida, United States

Site Status

Sarasota Memorial Hospital

Sarasota, Florida, United States

Site Status

VA Medical Center - Tampa

Tampa, Florida, United States

Site Status

Piedmont Athens Regional Medical Center

Athens, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Coliseum Medical Centers

Macon, Georgia, United States

Site Status

Redmond Regional Medical Center

Rome, Georgia, United States

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Illinois Heart and Vascular - Hinsdale

Hinsdale, Illinois, United States

Site Status

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status

Reid Health

Richmond, Indiana, United States

Site Status

Healient Physician Group

Leawood, Kansas, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

Jewish Hospital

Louisville, Kentucky, United States

Site Status

One Health Cardiology

Owensboro, Kentucky, United States

Site Status

Gregory C. Sampognaro Interventional Cardiology

Monroe, Louisiana, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Advanced Cardiovascular Specialists

Shreveport, Louisiana, United States

Site Status

LSU Health Sciences Center

Shreveport, Louisiana, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

MedStar Health Research Institute

Hyattsville, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Charlton Memorial Hospital

Fall River, Massachusetts, United States

Site Status

Trinity Health-Michigan d/b/a Michigan Heart

Ann Arbor, Michigan, United States

Site Status

Michigan Electrophysiology Specialists

Flushing, Michigan, United States

Site Status

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Site Status

MidMichigan Medical Center-Midland

Midland, Michigan, United States

Site Status

Michigan Cardiovascular Institute

Saginaw, Michigan, United States

Site Status

Providence Hospital

Southfield, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

Jackson Heart Clinic

Jackson, Mississippi, United States

Site Status

St. Luke's Hospital

Kansas City, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

St. Louis Heart and Vascular PC

St Louis, Missouri, United States

Site Status

Kearney Regional Medical Center

Kearney, Nebraska, United States

Site Status

BryanLGH Medical Center East

Lincoln, Nebraska, United States

Site Status

HealthCare Partners Cardiology

Las Vegas, Nevada, United States

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Catholic Medical Center

Manchester, New Hampshire, United States

Site Status

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Site Status

Atlantic Health System - Morristown Memorial Hospital

Morristown, New Jersey, United States

Site Status

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

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Presbyterian Heart Group

Albuquerque, New Mexico, United States

Site Status

St. Peter's Health Partners Medical Associates, PC

Albany, New York, United States

Site Status

Trinity Medical WNY, PC

Buffalo, New York, United States

Site Status

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, United States

Site Status

VA Medical Center Durham

Durham, North Carolina, United States

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Highpoint Regional Hospital

High Point, North Carolina, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University Hospitals Elyria Medical Center

Elyria, Ohio, United States

Site Status

Middletown Cardiovascular Associates

Middletown, Ohio, United States

Site Status

Samaritan Heart & Vascular Institute - Cardiology Dept.

Corvallis, Oregon, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Presbyterian Medical Center (PA)

Philadelphia, Pennsylvania, United States

Site Status

Scranton Cardiovascular Physicians

Scranton, Pennsylvania, United States

Site Status

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, United States

Site Status

Pee Dee Cardiology Associates, PA

Florence, South Carolina, United States

Site Status

St. Francis Hospital

Greenville, South Carolina, United States

Site Status

Lexington Cardiology

Lexington, South Carolina, United States

Site Status

Mountain States Medical Group Cardiology

Johnson City, Tennessee, United States

Site Status

Cardiovascular Associates, PC (Wellmont Holston Valley M C)

Kingsport, Tennessee, United States

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Methodist University Hospital

Memphis, Tennessee, United States

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Austin Heart

Austin, Texas, United States

Site Status

HeartPlace

Bedford, Texas, United States

Site Status

Fort Worth Heart

Fort Worth, Texas, United States

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Houston Cardiovascular Associates

Houston, Texas, United States

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Memorial Hermann Hospital

Houston, Texas, United States

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South Texas Cardiovascular Consultants

San Antonio, Texas, United States

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Cardiology Clinic Of San Antonio Pa

San Antonio, Texas, United States

Site Status

Wichita Falls Heart Clinic

Wichita Falls, Texas, United States

Site Status

McKay-Dee Heart Services

Ogden, Utah, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Virginia Heart - The Cardiovascular Group, P.C.

Falls Church, Virginia, United States

Site Status

Bayview Physicians Services, PC

Virginia Beach, Virginia, United States

Site Status

Kootenai Heart Clinics

Spokane, Washington, United States

Site Status

St. Mary's Hospital

Huntington, West Virginia, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Aspirus Wausau Hospital

Wausau, Wisconsin, United States

Site Status

Wheaton Franciscan Medical Group - Heart Rhythm Specialists

Wauwatosa, Wisconsin, United States

Site Status

Instituto Argentino de Diagnostico y Tratamiento

Caba, Buenos Aires, Argentina

Site Status

Fundacion Favaloro para la Docencia e Inv. med.

Buenos Aires, Rio de La Plata, Argentina

Site Status

Instituto Cardiovascular Buenos Aires (ICBA)

Buenos Aires, Rio de La Plata, Argentina

Site Status

Fundacion Clinica Shaio

Bogota, Antioquia, Colombia

Site Status

APEX Foundation

Medellín, Antioquia, Colombia

Site Status

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Site Status

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Site Status

Akashi Medical Center

Hyōgo, Kinki, Japan

Site Status

Tohoku University Hospital

Sendai, Miyagi, Japan

Site Status

Tokyo Women's Medical University

Shinjuku-Ku, Tokyo, Japan

Site Status

Chiba University

Chiba, , Japan

Site Status

St. Marianna University School of Medicine Hospital

Kanagawa, , Japan

Site Status

Shinshu University Hospital

Matsumoto, , Japan

Site Status

Niigata University Medical & Dental Hospital

Niigata, , Japan

Site Status

Sakurabashi Watanabe Hospital

Osaka, , Japan

Site Status

National Cerebral and Cardiovascular Center Hospital

Osaka, , Japan

Site Status

Osaka University Hospital

Osaka, , Japan

Site Status

University of Tsukuba Hospital

Tsukuba, , Japan

Site Status

Countries

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United States Argentina Colombia Japan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SJM-CIP-10149

Identifier Type: -

Identifier Source: org_study_id

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