MultiPoint Pacing™ Post Market Study (MPP-PMS)

February 9, 2021 updated by: Abbott Medical Devices
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2169

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

  • Argentina
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1122AAL
        • Instituto Argentino de Diagnóstico y Tratamiento
    • Rio De La Plata
      • Buenos Aires, Rio De La Plata, Argentina, C1093AAS
        • Fundacion Favaloro para la Docencia e Inv. med.
      • Buenos Aires, Rio De La Plata, Argentina, C1428ART
        • Instituto Cardiovascular Buenos Aires (ICBA)
  • Colombia
    • Antioquia
      • Bogota, Antioquia, Colombia, 110111
        • Fundación Clínica Shaio
      • Medellin, Antioquia, Colombia, 1104
        • APEX Foundation
  • Japan
      • Chiba, Japan, 2608677
        • Chiba University
      • Kanagawa, Japan, 2168511
        • St. Marianna University School of Medicine Hospital
      • Matsumoto, Japan, 3908621
        • Shinshu University Hospital
      • Niigata, Japan, 9518510
        • Niigata University Medical & Dental Hospital
      • Osaka, Japan, 5300001
        • Sakurabashi Watanabe Hospital
      • Osaka, Japan, 5658565
        • National Cerebral and Cardiovascular Center Hospital
      • Osaka, Japan, 6560871
        • Osaka University Hospital
      • Tsukuba, Japan, 3058576
        • University of Tsukuba Hospital
    • Aomori
      • Hirosaki, Aomori, Japan, 0368203
        • Hirosaki University Hospital
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 8020001
        • Kokura Memorial Hospital
    • Kinki
      • Hyogo, Kinki, Japan, 6740063
        • Akashi Medical Center
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 1628666
        • Tokyo Women's Medical University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University Hospital - Univ. of Alabama at Birmingham (UAB)
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC.
    • Arizona
      • Avondale, Arizona, United States, 85392
        • Integrated Medical Services
      • Glendale, Arizona, United States, 85306
        • Cardiovascular Consultants Ltd
      • Phoenix, Arizona, United States, 85018
        • Phoenix Cardiovascular Research Group
      • Phoenix, Arizona, United States, 85013
        • Arizona Arrhythmia Research Center
      • Phoenix, Arizona, United States, 85020
        • John C. Lincoln North Mountain Hospital
      • Scottsdale, Arizona, United States, 85251
        • Arizona Arrhythmia Consultants
    • California
      • Alhambra, California, United States, 91801
        • Comprehensive Cardiovascular Specialists
      • Los Angeles, California, United States, 90033
        • USC University Hospital
      • Los Angeles, California, United States, 90048
        • Jeffrey Goodman
      • Newport Beach, California, United States, 92663
        • Premier Cardiology, Inc
      • Palm Springs, California, United States, 92262
        • Desert Heart Rhythm Consultants
      • Pomona, California, United States, 91767
        • Chaparral Medical Group
      • Reseda, California, United States, 91335
        • Cardiac Rhythm Specialists, Inc.
      • San Diego, California, United States, 92123
        • San Diego Cardiac Center
      • Torrance, California, United States, 90505
        • COR Healthcare Medical Associates
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Denver Cardiology Associates, P.C.
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Cardiology Associates of Fairfield County, PC
    • Florida
      • Boca Raton, Florida, United States, 33422
        • Cardiac Arrhythmia Services
      • Delray Beach, Florida, United States, 33484
        • Yoel R. Vivas, MD
      • Hollywood, Florida, United States, 33021
        • Heart Rhythm Solutions
      • Inverness, Florida, United States, 34452
        • Citrus Cardiology Consultants, PA
      • Jacksonville, Florida, United States, 32204
        • St. Vincent's Medical Center
      • Kissimmee, Florida, United States, 34741
        • Naushad Shaik, MD
      • Lake Mary, Florida, United States, 32746
        • Jorge Diaz, M.D., P.A.
      • New Smyrna Beach, Florida, United States, 32168
        • Central Florida Medical Research
      • Orlando, Florida, United States, 32837
        • Usman R. Siddiqui, MD
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital
      • Rockledge, Florida, United States, 32955
        • Brevard Cardiovascular Research Associates, Inc.
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • Tampa, Florida, United States, 33612
        • VA Medical Center - Tampa
    • Georgia
      • Athens, Georgia, United States, 30606
        • Piedmont Athens Regional Medical Center
      • Atlanta, Georgia, United States, 30342
        • Emory University Hospital
      • Macon, Georgia, United States, 31201
        • Coliseum Medical Centers
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Illinois Heart and Vascular - Hinsdale
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Reid Health
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Healient Physician Group
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
      • Owensboro, Kentucky, United States, 42304
        • One Health Cardiology
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Gregory C. Sampognaro Interventional Cardiology
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
      • Shreveport, Louisiana, United States, 71130
        • LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71103
        • Advanced Cardiovascular Specialists
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Fall River, Massachusetts, United States, 02720
        • Charlton Memorial Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health-Michigan d/b/a Michigan Heart
      • Flushing, Michigan, United States, 48433
        • Michigan Electrophysiology Specialists
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Midland, Michigan, United States, 48670
        • MidMichigan Medical Center-Midland
      • Saginaw, Michigan, United States, 48601
        • Michigan Cardiovascular Institute
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63136
        • St. Louis Heart and Vascular PC
    • Nebraska
      • Kearney, Nebraska, United States, 68845
        • Kearney Regional Medical Center
      • Lincoln, Nebraska, United States, 68506-1299
        • BryanLGH Medical Center East
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • HealthCare Partners Cardiology
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Morristown, New Jersey, United States, 07962
        • Atlantic Health System - Morristown Memorial Hospital
      • Neptune, New Jersey, United States, 08015
        • Jersey Shore University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Presbyterian Heart Group
    • New York
      • Albany, New York, United States, 12205
        • St. Peter's Health Partners Medical Associates, PC
      • Buffalo, New York, United States, 14215
        • Trinity Medical WNY, PC
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart and Vascular Research Institute
      • Durham, North Carolina, United States, 27705
        • VA Medical Center Durham
      • High Point, North Carolina, United States, 27262
        • Highpoint Regional Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Elyria, Ohio, United States, 44035
        • University Hospitals Elyria Medical Center
      • Middletown, Ohio, United States, 45044
        • Middletown Cardiovascular Associates
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Samaritan Heart & Vascular Institute - Cardiology Dept.
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2150
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Presbyterian Medical Center (PA)
      • Scranton, Pennsylvania, United States, 18510
        • Scranton Cardiovascular Physicians
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • South Carolina
      • Florence, South Carolina, United States, 29506
        • Pee Dee Cardiology Associates, PA
      • Greenville, South Carolina, United States, 29601
        • St. Francis Hospital
      • Lexington, South Carolina, United States, 29204
        • Lexington Cardiology
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Mountain States Medical Group Cardiology
      • Kingsport, Tennessee, United States, 37660
        • Cardiovascular Associates, PC (Wellmont Holston Valley M C)
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Bedford, Texas, United States, 76021
        • HeartPlace
      • Fort Worth, Texas, United States, 76104
        • Fort Worth Heart
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
      • Houston, Texas, United States, 77030
        • Houston Cardiovascular Associates
      • San Antonio, Texas, United States, 78201
        • South Texas Cardiovascular Consultants
      • San Antonio, Texas, United States, 78229
        • Cardiology Clinic Of San Antonio Pa
      • Wichita Falls, Texas, United States, 76301
        • Wichita Falls Heart Clinic
    • Utah
      • Ogden, Utah, United States, 84403
        • McKay-Dee Heart Services
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart - The Cardiovascular Group, P.C.
      • Virginia Beach, Virginia, United States, 23454
        • Bayview Physicians Services, PC
    • Washington
      • Spokane, Washington, United States, 92204
        • Kootenai Heart Clinics
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Hospital
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Wausau Hospital
      • Wauwatosa, Wisconsin, United States, 53226
        • Wheaton Franciscan Medical Group - Heart Rhythm Specialists

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CRT Responders as Measured by the Clinical Composite Score (CCS)
Time Frame: One year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: baseline and one year

The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline).

MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
baseline and one year
Duration of MPP Programming in Months
Time Frame: One year
The duration of MPP programming in months in the treatment groups.
One year
Number of MPP Programming Optimizations Per Subject
Time Frame: One year
The number of MPP programming optimizations per subject
One year
Number of Subjects With Heart Failure Hospitalization
Time Frame: One year

HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure:

  • Hospitalization for HF ≥ 24 hours
  • Clinic or hospital visit for HF<24 hours (i.e. outpatient treatment, observational care, ER, Urgent Care and physician's office visit) requiring administration of IV diuretics, inotropes, and/or vasodilators
One year
Number of Subjects With Cardiovascular Hospitalization
Time Frame: One year
Number of subjects with cardiovascular hospitalization as reported by the sites
One year
Number of Subjects With Heart Failure 30-day Hospitalization
Time Frame: 30 days
Number of subjects with heart failure 30-day hospitalization as reported by the sites
30 days
Number of Deaths
Time Frame: One year
Overall mortality rate for all subjects who started the trial is summarized.
One year
Change in Left Ventricular Ejection Fraction
Time Frame: baseline and one year
Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline)
baseline and one year
Change in Left Ventricular End Systolic Volume
Time Frame: baseline and one year
Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months)
baseline and one year

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Clay Cohorn, Abbott Medical Devices

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

July 1, 2016

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

July 15, 2019

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJM-CIP-10149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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