Clinical trial NCT01786993: MultiPoint Pacing IDE Study
Official title: MultiPoint Pacing IDE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.

The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.

Detailed description: All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is programmed using any one of the 10 available pacing vectors. The paced/sensed atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up visit.

At the 3-month visit, responder status between Enrollment and 3 months will be assessed using the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened" or "Unchanged" using the definitions outlined in the CCS will be considered as Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g., Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with "equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm or MPP arm.

At the 9-month visit, responder status will be evaluated once again using the CCS and compared to the status at 3 months.

Eligibility criteria: Inclusion Criteria:

* Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)
* Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV 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:

* Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment
* Have an existing Class I recalled lead
* Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
* Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months
* Have permanent atrial fibrillation (AF)
* Have undergone a cardiac transplantation within 40 days of enrollment
* Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant.
* Are currently participating in a clinical investigation that includes an active treatment arm
* Are pregnant or planning to become pregnant during the duration of the study
* Have a life expectancy of less than 9 months due to any condition
* Are less than 18 years of age

Primary outcomes:
measure: Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion
timeFrame: Implant to 9 months
measure: Percentage of Non-responders With MPP Compared to Biventricular Pacing
timeFrame: 3 months to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Mesa
country: United States
facility: Banner Heart Hospital
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Newport Beach
country: United States
facility: Premier Cardiology, Inc
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: Lakewood
country: United States
facility: Colorado Heart & Vascular, P.C.
state: Colorado
city: Norwalk
country: United States
facility: Cardiology Associates of Fairfield County, PC
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Brandon
country: United States
facility: Bay Area Cardiology Associates PA
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Peoria
country: United States
facility: HeartCare Midwest
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic Cardio Healthcare Foundation
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: New York
country: United States
facility: New York Presbyterian Hospital/Cornell University
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Research Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Medical Center Clinical Sciences
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
city: Amarillo
country: United States
facility: Cardiology Center of Amarillo, L.L.P
state: Texas
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Virginia Beach
country: United States
facility: Cardiovascular Associates, LTD
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Wausau Hospital
state: Wisconsin
Study officials:
affiliation: Central Baptist Hospital
name: Gery Tomassoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varma N, Baker J 2nd, Tomassoni G, Love CJ, Martin D, Sheppard R, Niazi I, Cranke G, Lee K, Corbisiero R. Left Ventricular Enlargement, Cardiac Resynchronization Therapy Efficacy, and Impact of MultiPoint Pacing. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008680. doi: 10.1161/CIRCEP.120.008680. Epub 2020 Oct 7.
citation: Niazi I, Baker J 2nd, Corbisiero R, Love C, Martin D, Sheppard R, Worley SJ, Varma N, Lee K, Tomassoni G; MPP Investigators. Safety and Efficacy of Multipoint Pacing in Cardiac Resynchronization Therapy: The MultiPoint Pacing Trial. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1510-1518. doi: 10.1016/j.jacep.2017.06.022. Epub 2017 Sep 27.