MultiPoint Pacing™ Post Market Study

Completed

Conditions: Heart Failure

Interventions: Device: MPP
Device: BiV/MPP

Registration Number: NCT02832622

Lead Sponsor: Abbott Medical Devices

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2169

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MPP Programming	BiV/MPP	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 Programming	MPP	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.

Primary Outcome Measures

Name	Time	Method
Number of CRT Responders as Measured by the Clinical Composite Score (CCS)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (128): LSU Health Sciences Center
🇺🇸
Shreveport, Louisiana, United States
BryanLGH Medical Center East
🇺🇸
Lincoln, Nebraska, United States
Aspirus Wausau Hospital
🇺🇸
Wausau, Wisconsin, United States
Providence Hospital
🇺🇸
Southfield, Michigan, United States
Boston Medical Center
🇺🇸
Boston, Massachusetts, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Houston Cardiovascular Associates
🇺🇸
Houston, Texas, United States
Memorial Hermann Hospital
🇺🇸
Houston, Texas, United States
San Diego Cardiac Center
🇺🇸
San Diego, California, United States
HealthCare Partners Cardiology
🇺🇸
Las Vegas, Nevada, United States
Kearney Regional Medical Center
🇺🇸
Kearney, Nebraska, United States
Instituto Cardiovascular Buenos Aires (ICBA)
🇦🇷
Buenos Aires, Rio De La Plata, Argentina
Jackson Heart Clinic
🇺🇸
Jackson, Mississippi, United States
Methodist University Hospital
🇺🇸
Memphis, Tennessee, United States
Cardiology Associates of Fairfield County, PC
🇺🇸
Norwalk, Connecticut, United States
St. Francis Hospital
🇺🇸
Greenville, South Carolina, United States
Robert Wood Johnson University Hospital
🇺🇸
New Brunswick, New Jersey, United States
Pee Dee Cardiology Associates, PA
🇺🇸
Florence, South Carolina, United States
St. Vincent's Medical Center
🇺🇸
Jacksonville, Florida, United States
Gregory C. Sampognaro Interventional Cardiology
🇺🇸
Monroe, Louisiana, United States
Instituto Argentino de Diagnostico y Tratamiento
🇦🇷
Caba, Buenos Aires, Argentina
Arizona Arrhythmia Consultants
🇺🇸
Scottsdale, Arizona, United States
Hirosaki University Hospital
🇯🇵
Hirosaki, Aomori, Japan
Sakurabashi Watanabe Hospital
🇯🇵
Osaka, Japan
Cardiovascular Associates, PC (Wellmont Holston Valley M C)
🇺🇸
Kingsport, Tennessee, United States
Atlantic Health System - Morristown Memorial Hospital
🇺🇸
Morristown, New Jersey, United States
Fundacion Favaloro para la Docencia e Inv. med.
🇦🇷
Buenos Aires, Rio De La Plata, Argentina
Kokura Memorial Hospital
🇯🇵
Kitakyushu, Fukuoka, Japan
Osaka University Hospital
🇯🇵
Osaka, Japan
Shinshu University Hospital
🇯🇵
Matsumoto, Japan
National Cerebral and Cardiovascular Center Hospital
🇯🇵
Osaka, Japan
Heart Center Research, LLC.
🇺🇸
Huntsville, Alabama, United States
Comprehensive Cardiovascular Specialists
🇺🇸
Alhambra, California, United States
Premier Cardiology, Inc
🇺🇸
Newport Beach, California, United States
Cardiovascular Consultants Ltd
🇺🇸
Glendale, Arizona, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸
Reseda, California, United States
Jeffrey Goodman
🇺🇸
Los Angeles, California, United States
Desert Heart Rhythm Consultants
🇺🇸
Palm Springs, California, United States
Naushad Shaik, MD
🇺🇸
Kissimmee, Florida, United States
Healient Physician Group
🇺🇸
Leawood, Kansas, United States
Heart Rhythm Solutions
🇺🇸
Hollywood, Florida, United States
Sarasota Memorial Hospital
🇺🇸
Sarasota, Florida, United States
Coliseum Medical Centers
🇺🇸
Macon, Georgia, United States
Brevard Cardiovascular Research Associates, Inc.
🇺🇸
Rockledge, Florida, United States
Sacred Heart Hospital
🇺🇸
Pensacola, Florida, United States
Central Florida Medical Research
🇺🇸
New Smyrna Beach, Florida, United States
Redmond Regional Medical Center
🇺🇸
Rome, Georgia, United States
Illinois Heart and Vascular - Hinsdale
🇺🇸
Hinsdale, Illinois, United States
St. Louis Heart and Vascular PC
🇺🇸
Saint Louis, Missouri, United States
Michigan Cardiovascular Institute
🇺🇸
Saginaw, Michigan, United States
One Health Cardiology
🇺🇸
Owensboro, Kentucky, United States
Eastern Maine Medical Center
🇺🇸
Bangor, Maine, United States
Munson Medical Center
🇺🇸
Traverse City, Michigan, United States
Missouri Baptist Medical Center
🇺🇸
Saint Louis, Missouri, United States
Advanced Cardiovascular Specialists
🇺🇸
Shreveport, Louisiana, United States
MedStar Health Research Institute
🇺🇸
Hyattsville, Maryland, United States
St. Peter's Health Partners Medical Associates, PC
🇺🇸
Albany, New York, United States
Presbyterian Heart Group
🇺🇸
Albuquerque, New Mexico, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Jersey Shore University Medical Center
🇺🇸
Neptune, New Jersey, United States
Trinity Medical WNY, PC
🇺🇸
Buffalo, New York, United States
University of Tsukuba Hospital
🇯🇵
Tsukuba, Japan
Lexington Cardiology
🇺🇸
Lexington, South Carolina, United States
HeartPlace
🇺🇸
Bedford, Texas, United States
Scranton Cardiovascular Physicians
🇺🇸
Scranton, Pennsylvania, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
McKay-Dee Heart Services
🇺🇸
Ogden, Utah, United States
Middletown Cardiovascular Associates
🇺🇸
Middletown, Ohio, United States
Mountain States Medical Group Cardiology
🇺🇸
Johnson City, Tennessee, United States
APEX Foundation
🇨🇴
Medellin, Antioquia, Colombia
Gundersen Lutheran Medical Center
🇺🇸
La Crosse, Wisconsin, United States
Fundacion Clinica Shaio
🇨🇴
Bogota, Antioquia, Colombia
Fort Worth Heart
🇺🇸
Fort Worth, Texas, United States
Virginia Heart - The Cardiovascular Group, P.C.
🇺🇸
Falls Church, Virginia, United States
Akashi Medical Center
🇯🇵
Hyogo, Kinki, Japan
Tohoku University Hospital
🇯🇵
Sendai, Miyagi, Japan
Tokyo Women's Medical University
🇯🇵
Shinjuku-Ku, Tokyo, Japan
Chiba University
🇯🇵
Chiba, Japan
St. Marianna University School of Medicine Hospital
🇯🇵
Kanagawa, Japan
University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸
Birmingham, Alabama, United States
Arizona Arrhythmia Research Center
🇺🇸
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
🇺🇸
Phoenix, Arizona, United States
John C. Lincoln North Mountain Hospital
🇺🇸
Phoenix, Arizona, United States
South Texas Cardiovascular Consultants
🇺🇸
San Antonio, Texas, United States
Cardiology Clinic Of San Antonio Pa
🇺🇸
San Antonio, Texas, United States
University of Utah Hospital
🇺🇸
Salt Lake City, Utah, United States
VA Medical Center Durham
🇺🇸
Durham, North Carolina, United States
Providence St. Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Chaparral Medical Group
🇺🇸
Pomona, California, United States
COR Healthcare Medical Associates
🇺🇸
Torrance, California, United States
Cardiac Arrhythmia Services
🇺🇸
Boca Raton, Florida, United States
Yoel R. Vivas, MD
🇺🇸
Delray Beach, Florida, United States
Citrus Cardiology Consultants, PA
🇺🇸
Inverness, Florida, United States
Jorge Diaz, M.D., P.A.
🇺🇸
Lake Mary, Florida, United States
Reid Health
🇺🇸
Richmond, Indiana, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Highpoint Regional Hospital
🇺🇸
High Point, North Carolina, United States
University Hospitals Elyria Medical Center
🇺🇸
Elyria, Ohio, United States
Samaritan Heart & Vascular Institute - Cardiology Dept.
🇺🇸
Corvallis, Oregon, United States
Michigan Electrophysiology Specialists
🇺🇸
Flushing, Michigan, United States
Sparrow Clinical Research Institute
🇺🇸
Lansing, Michigan, United States
Bayview Physicians Services, PC
🇺🇸
Virginia Beach, Virginia, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
Wheaton Franciscan Medical Group - Heart Rhythm Specialists
🇺🇸
Wauwatosa, Wisconsin, United States
Kootenai Heart Clinics
🇺🇸
Spokane, Washington, United States
University of Virginia Medical Center
🇺🇸
Charlottesville, Virginia, United States
USC University Hospital
🇺🇸
Los Angeles, California, United States
Integrated Medical Services
🇺🇸
Avondale, Arizona, United States
Piedmont Athens Regional Medical Center
🇺🇸
Athens, Georgia, United States
MidMichigan Medical Center-Midland
🇺🇸
Midland, Michigan, United States
Charlton Memorial Hospital
🇺🇸
Fall River, Massachusetts, United States
Deborah Heart and Lung Center
🇺🇸
Browns Mills, New Jersey, United States
Catholic Medical Center
🇺🇸
Manchester, New Hampshire, United States
Presbyterian Medical Center (PA)
🇺🇸
Philadelphia, Pennsylvania, United States
Cardiology Consultants of Philadelphia
🇺🇸
Yardley, Pennsylvania, United States
Wichita Falls Heart Clinic
🇺🇸
Wichita Falls, Texas, United States
Niigata University Medical & Dental Hospital
🇯🇵
Niigata, Japan
Aurora Denver Cardiology Associates, P.C.
🇺🇸
Aurora, Colorado, United States
Usman R. Siddiqui, MD
🇺🇸
Orlando, Florida, United States
VA Medical Center - Tampa
🇺🇸
Tampa, Florida, United States
Trinity Health-Michigan d/b/a Michigan Heart
🇺🇸
Ann Arbor, Michigan, United States
Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
St. Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
Ochsner Medical Center
🇺🇸
New Orleans, Louisiana, United States
Austin Heart
🇺🇸
Austin, Texas, United States
Novant Health Heart and Vascular Research Institute
🇺🇸
Charlotte, North Carolina, United States
St. Mary's Hospital
🇺🇸
Huntington, West Virginia, United States