MultiPoint Pacing™ Post Market Study

Heart Failure Clinical Trial

— MPP-PMS  

Official title:

MultiPoint Pacing™ Post Market Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832622
• Other study ID #: SJM-CIP-10149
• Status: Completed
• Start date: July 2016
• Est. completion date: July 15, 2019

Study information

• Verified date: February 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2169
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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)
• 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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Argentina,  Colombia,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of Life	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
Other	Duration of MPP Programming in Months	The duration of MPP programming in months in the treatment groups.	One year
Other	Number of MPP Programming Optimizations Per Subject	The number of MPP programming optimizations per subject	One year
Other	Number of Subjects With Heart Failure Hospitalization	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
Other	Number of Subjects With Cardiovascular Hospitalization	Number of subjects with cardiovascular hospitalization as reported by the sites	One year
Other	Number of Subjects With Heart Failure 30-day Hospitalization	Number of subjects with heart failure 30-day hospitalization as reported by the sites	30 days
Other	Number of Deaths	Overall mortality rate for all subjects who started the trial is summarized.	One year
Other	Change in Left Ventricular Ejection Fraction	Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline)	baseline and one year
Other	Change in Left Ventricular End Systolic Volume	Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months)	baseline and one year
Primary	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