MultiPoint Pacing™ Post Market Study

NCT02832622 | Completed Results

• 1 other identifier: SJM-CIP-10149
• Study Type: observational
• Target: 2,169
• Locations: 4 countries
• Sites: 128

Brief Summary

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.

Conditions

Heart Failure

Keywords

MultiPoint Pacing; Heart Failure; Cardiac Resynchronization Therapy; SJM Quadripolar Biventricular Pacing

Outcome Measures

Primary Outcomes (1)

• Number of CRT Responders as Measured by the Clinical Composite Score (CCS)

  The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.

  One year

Other Outcomes (9)

• Change in Quality of Life

  baseline and one year

• Duration of MPP Programming in Months

  One year

• Number of MPP Programming Optimizations Per Subject

  One year

Study Arms (1)

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.

Device: MPP; Device: BiV/MPP

Interventions

MPP 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)

MPP Programming

BiV/MPP 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)

MPP Programming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are indiciated for a Cardiac Resynchronization Therapy (CRT) device

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (128)

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

Birmingham, Alabama, 35249, United States

Location

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Integrated Medical Services

Avondale, Arizona, 85392, United States

Location

Cardiovascular Consultants Ltd

Glendale, Arizona, 85306, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85013, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

John C. Lincoln North Mountain Hospital

Phoenix, Arizona, 85020, United States

Location

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85251, United States

Location

Comprehensive Cardiovascular Specialists

Alhambra, California, 91801, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Jeffrey Goodman

Los Angeles, California, 90048, United States

Location

Premier Cardiology, Inc

Newport Beach, California, 92663, United States

Location

Desert Heart Rhythm Consultants

Palm Springs, California, 92262, United States

Location

Chaparral Medical Group

Pomona, California, 91767, United States

Location

Cardiac Rhythm Specialists, Inc.

Reseda, California, 91335, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

COR Healthcare Medical Associates

Torrance, California, 90505, United States

Location

Aurora Denver Cardiology Associates, P.C.

Aurora, Colorado, 80012, United States

Location

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, 06851, United States

Location

Cardiac Arrhythmia Services

Boca Raton, Florida, 33422, United States

Location

Yoel R. Vivas, MD

Delray Beach, Florida, 33484, United States

Location

Heart Rhythm Solutions

Hollywood, Florida, 33021, United States

Location

Citrus Cardiology Consultants, PA

Inverness, Florida, 34452, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Naushad Shaik, MD

Kissimmee, Florida, 34741, United States

Location

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

Lake Mary, Florida, 32746, United States

Location

Central Florida Medical Research

New Smyrna Beach, Florida, 32168, United States

Location

Usman R. Siddiqui, MD

Orlando, Florida, 32837, United States

Location

Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

Brevard Cardiovascular Research Associates, Inc.

Rockledge, Florida, 32955, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

VA Medical Center - Tampa

Tampa, Florida, 33612, United States

Location

Piedmont Athens Regional Medical Center

Athens, Georgia, 30606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30342, United States

Location

Coliseum Medical Centers

Macon, Georgia, 31201, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

Illinois Heart and Vascular - Hinsdale

Hinsdale, Illinois, 60521, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Reid Health

Richmond, Indiana, 47374, United States

Location

Healient Physician Group

Leawood, Kansas, 66211, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

One Health Cardiology

Owensboro, Kentucky, 42304, United States

Location

Gregory C. Sampognaro Interventional Cardiology

Monroe, Louisiana, 71201, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Advanced Cardiovascular Specialists

Shreveport, Louisiana, 71103, United States

Location

LSU Health Sciences Center

Shreveport, Louisiana, 71130, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Charlton Memorial Hospital

Fall River, Massachusetts, 02720, United States

Location

Trinity Health-Michigan d/b/a Michigan Heart

Ann Arbor, Michigan, 48106, United States

Location

Michigan Electrophysiology Specialists

Flushing, Michigan, 48433, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

MidMichigan Medical Center-Midland

Midland, Michigan, 48670, United States

Location

Michigan Cardiovascular Institute

Saginaw, Michigan, 48601, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

St. Louis Heart and Vascular PC

St Louis, Missouri, 63136, United States

Location

Kearney Regional Medical Center

Kearney, Nebraska, 68845, United States

Location

BryanLGH Medical Center East

Lincoln, Nebraska, 68506-1299, United States

Location

HealthCare Partners Cardiology

Las Vegas, Nevada, 89169, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Atlantic Health System - Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 08015, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Presbyterian Heart Group

Albuquerque, New Mexico, 87106, United States

Location

St. Peter's Health Partners Medical Associates, PC

Albany, New York, 12205, United States

Location

Trinity Medical WNY, PC

Buffalo, New York, 14215, United States

Location

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, 28204, United States

Location

VA Medical Center Durham

Durham, North Carolina, 27705, United States

Location

Highpoint Regional Hospital

High Point, North Carolina, 27262, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University Hospitals Elyria Medical Center

Elyria, Ohio, 44035, United States

Location

Middletown Cardiovascular Associates

Middletown, Ohio, 45044, United States

Location

Samaritan Heart & Vascular Institute - Cardiology Dept.

Corvallis, Oregon, 97330, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2150, United States

Location

Presbyterian Medical Center (PA)

Philadelphia, Pennsylvania, 19104, United States

Location

Scranton Cardiovascular Physicians

Scranton, Pennsylvania, 18510, United States

Location

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, 19067, United States

Location

Pee Dee Cardiology Associates, PA

Florence, South Carolina, 29506, United States

Location

St. Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Lexington Cardiology

Lexington, South Carolina, 29204, United States

Location

Mountain States Medical Group Cardiology

Johnson City, Tennessee, 37601, United States

Location

Cardiovascular Associates, PC (Wellmont Holston Valley M C)

Kingsport, Tennessee, 37660, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

HeartPlace

Bedford, Texas, 76021, United States

Location

Fort Worth Heart

Fort Worth, Texas, 76104, United States

Location

Houston Cardiovascular Associates

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78201, United States

Location

Cardiology Clinic Of San Antonio Pa

San Antonio, Texas, 78229, United States

Location

Wichita Falls Heart Clinic

Wichita Falls, Texas, 76301, United States

Location

McKay-Dee Heart Services

Ogden, Utah, 84403, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Virginia Heart - The Cardiovascular Group, P.C.

Falls Church, Virginia, 22042, United States

Location

Bayview Physicians Services, PC

Virginia Beach, Virginia, 23454, United States

Location

Kootenai Heart Clinics

Spokane, Washington, 92204, United States

Location

St. Mary's Hospital

Huntington, West Virginia, 25702, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Wheaton Franciscan Medical Group - Heart Rhythm Specialists

Wauwatosa, Wisconsin, 53226, United States

Location

Instituto Argentino de Diagnostico y Tratamiento

Caba, Buenos Aires, C1122AAL, Argentina

Location

Fundacion Favaloro para la Docencia e Inv. med.

Buenos Aires, Rio de La Plata, C1093AAS, Argentina

Location

Instituto Cardiovascular Buenos Aires (ICBA)

Buenos Aires, Rio de La Plata, C1428ART, Argentina

Location

Fundacion Clinica Shaio

Bogota, Antioquia, 110111, Colombia

Location

APEX Foundation

Medellín, Antioquia, 1104, Colombia

Location

Hirosaki University Hospital

Hirosaki, Aomori, 0368203, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 8020001, Japan

Location

Akashi Medical Center

Hyōgo, Kinki, 6740063, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 9808574, Japan

Location

Tokyo Women's Medical University

Shinjuku-Ku, Tokyo, 1628666, Japan

Location

Chiba University

Chiba, 2608677, Japan

Location

St. Marianna University School of Medicine Hospital

Kanagawa, 2168511, Japan

Location

Shinshu University Hospital

Matsumoto, 3908621, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, 9518510, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, 5300001, Japan

Location

National Cerebral and Cardiovascular Center Hospital

Osaka, 5658565, Japan

Location

Osaka University Hospital

Osaka, 6560871, Japan

Location

University of Tsukuba Hospital

Tsukuba, 3058576, Japan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kwangdeok Lee, PhD
• Organization: Abbott

kwangdeok.lee@abbott.com

1-972-526-9673

Study Officials

• Clay Cohorn

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2016
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-02

Locations

CO (2); JP (13); AR (3); US (110)