Clinical trial NCT02832622: MultiPoint Pacing™ Post Market Study
Official title: MultiPoint Pacing™ Post Market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: MultiPoint Pacing
Heart Failure
Cardiac Resynchronization Therapy
SJM Quadripolar Biventricular Pacing
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 2169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are indiciated for a Cardiac Resynchronization Therapy (CRT) device

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of CRT Responders as Measured by the Clinical Composite Score (CCS)
timeFrame: One year
Secondary outcomes:
Other outcomes:
measure: Change in Quality of Life
timeFrame: baseline and one year
measure: Duration of MPP Programming in Months
timeFrame: One year
measure: Number of MPP Programming Optimizations Per Subject
timeFrame: One year
measure: Number of Subjects With Heart Failure Hospitalization
timeFrame: One year
measure: Number of Subjects With Cardiovascular Hospitalization
timeFrame: One year
measure: Number of Subjects With Heart Failure 30-day Hospitalization
timeFrame: 30 days
measure: Number of Deaths
timeFrame: One year
measure: Change in Left Ventricular Ejection Fraction
timeFrame: baseline and one year
measure: Change in Left Ventricular End Systolic Volume
timeFrame: baseline and one year
Locations:
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Avondale
country: United States
facility: Integrated Medical Services
state: Arizona
city: Glendale
country: United States
facility: Cardiovascular Consultants Ltd
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Phoenix
country: United States
facility: John C. Lincoln North Mountain Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Alhambra
country: United States
facility: Comprehensive Cardiovascular Specialists
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Jeffrey Goodman
state: California
city: Newport Beach
country: United States
facility: Premier Cardiology, Inc
state: California
city: Palm Springs
country: United States
facility: Desert Heart Rhythm Consultants
state: California
city: Pomona
country: United States
facility: Chaparral Medical Group
state: California
city: Reseda
country: United States
facility: Cardiac Rhythm Specialists, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Torrance
country: United States
facility: COR Healthcare Medical Associates
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates, P.C.
state: Colorado
city: Norwalk
country: United States
facility: Cardiology Associates of Fairfield County, PC
state: Connecticut
city: Boca Raton
country: United States
facility: Cardiac Arrhythmia Services
state: Florida
city: Delray Beach
country: United States
facility: Yoel R. Vivas, MD
state: Florida
city: Hollywood
country: United States
facility: Heart Rhythm Solutions
state: Florida
city: Inverness
country: United States
facility: Citrus Cardiology Consultants, PA
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Naushad Shaik, MD
state: Florida
city: Lake Mary
country: United States
facility: Jorge Diaz, M.D., P.A.
state: Florida
city: New Smyrna Beach
country: United States
facility: Central Florida Medical Research
state: Florida
city: Orlando
country: United States
facility: Usman R. Siddiqui, MD
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Rockledge
country: United States
facility: Brevard Cardiovascular Research Associates, Inc.
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: VA Medical Center - Tampa
state: Florida
city: Athens
country: United States
facility: Piedmont Athens Regional Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Macon
country: United States
facility: Coliseum Medical Centers
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Hinsdale
country: United States
facility: Illinois Heart and Vascular - Hinsdale
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Richmond
country: United States
facility: Reid Health
state: Indiana
city: Leawood
country: United States
facility: Healient Physician Group
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Owensboro
country: United States
facility: One Health Cardiology
state: Kentucky
city: Monroe
country: United States
facility: Gregory C. Sampognaro Interventional Cardiology
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Advanced Cardiovascular Specialists
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Charlton Memorial Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Trinity Health-Michigan d/b/a Michigan Heart
state: Michigan
city: Flushing
country: United States
facility: Michigan Electrophysiology Specialists
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center-Midland
state: Michigan
city: Saginaw
country: United States
facility: Michigan Cardiovascular Institute
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular PC
state: Missouri
city: Kearney
country: United States
facility: Kearney Regional Medical Center
state: Nebraska
city: Lincoln
country: United States
facility: BryanLGH Medical Center East
state: Nebraska
city: Las Vegas
country: United States
facility: HealthCare Partners Cardiology
state: Nevada
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System - Morristown Memorial Hospital
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Albany
country: United States
facility: St. Peter's Health Partners Medical Associates, PC
state: New York
city: Buffalo
country: United States
facility: Trinity Medical WNY, PC
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Research Institute
state: North Carolina
city: Durham
country: United States
facility: VA Medical Center Durham
state: North Carolina
city: High Point
country: United States
facility: Highpoint Regional Hospital
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Elyria
country: United States
facility: University Hospitals Elyria Medical Center
state: Ohio
city: Middletown
country: United States
facility: Middletown Cardiovascular Associates
state: Ohio
city: Corvallis
country: United States
facility: Samaritan Heart & Vascular Institute - Cardiology Dept.
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian Medical Center (PA)
state: Pennsylvania
city: Scranton
country: United States
facility: Scranton Cardiovascular Physicians
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Florence
country: United States
facility: Pee Dee Cardiology Associates, PA
state: South Carolina
city: Greenville
country: United States
facility: St. Francis Hospital
state: South Carolina
city: Lexington
country: United States
facility: Lexington Cardiology
state: South Carolina
city: Johnson City
country: United States
facility: Mountain States Medical Group Cardiology
state: Tennessee
city: Kingsport
country: United States
facility: Cardiovascular Associates, PC (Wellmont Holston Valley M C)
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Bedford
country: United States
facility: HeartPlace
state: Texas
city: Fort Worth
country: United States
facility: Fort Worth Heart
state: Texas
city: Houston
country: United States
facility: Houston Cardiovascular Associates
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: San Antonio
country: United States
facility: Cardiology Clinic Of San Antonio Pa
state: Texas
city: Wichita Falls
country: United States
facility: Wichita Falls Heart Clinic
state: Texas
city: Ogden
country: United States
facility: McKay-Dee Heart Services
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Falls Church
country: United States
facility: Virginia Heart - The Cardiovascular Group, P.C.
state: Virginia
city: Virginia Beach
country: United States
facility: Bayview Physicians Services, PC
state: Virginia
city: Spokane
country: United States
facility: Kootenai Heart Clinics
state: Washington
city: Huntington
country: United States
facility: St. Mary's Hospital
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Wausau Hospital
state: Wisconsin
city: Wauwatosa
country: United States
facility: Wheaton Franciscan Medical Group - Heart Rhythm Specialists
state: Wisconsin
city: Caba
country: Argentina
facility: Instituto Argentino de Diagnostico y Tratamiento
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundacion Favaloro para la Docencia e Inv. med.
state: Rio De La Plata
city: Buenos Aires
country: Argentina
facility: Instituto Cardiovascular Buenos Aires (ICBA)
state: Rio De La Plata
city: Bogota
country: Colombia
facility: Fundacion Clinica Shaio
state: Antioquia
city: Medellin
country: Colombia
facility: APEX Foundation
state: Antioquia
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Hyogo
country: Japan
facility: Akashi Medical Center
state: Kinki
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University
city: Kanagawa
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Osaka
country: Japan
facility: National Cerebral and Cardiovascular Center Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
Study officials:
affiliation: Abbott Medical Devices
name: Clay Cohorn
role: STUDY_DIRECTOR
References: