MultiPoint Pacing IDE Study (MPP IDE)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: MultiPoint Pacing; Device: Traditional Biventricular Pacing

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.

• Study Type: Interventional
• Enrollment (Actual): 506
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC.
  • Arizona
    • Mesa, Arizona, United States, 85027
      • Banner Heart Hospital
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Glendale, California, United States, 91206
      • Glendale Memorial Hospital and Medical Center
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • Newport Beach, California, United States, 92663
      • Premier Cardiology, Inc
    • Sacramento, California, United States, 95819
      • Regional Cardiology Associates
    • Sacramento, California, United States, 95819
      • Sutter Memorial Hospital
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart & Vascular, P.C.
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Cardiology Associates of Fairfield County, PC
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital
  • Florida
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology Associates PA
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital Orlando
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Hospital
  • Illinois
    • Peoria, Illinois, United States, 61614
      • HeartCare Midwest
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Thoracic Cardio Healthcare Foundation
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
    • Morristown, New Jersey, United States, 07962
      • Morristown Memorial Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital/Cornell University
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Heart and Vascular Research Institute
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Medical Center Clinical Sciences
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43124
      • Ohio Health Research Institute
    • Toledo, Ohio, United States, 43606
      • The Toledo Hospital
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • York, Pennsylvania, United States, 17403
      • WellSpan Health
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • St. Thomas Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Heart and Vascular Institute
  • Texas
    • Amarillo, Texas, United States, 79106
      • Cardiology Center of Amarillo, L.L.P
    • Austin, Texas, United States, 78756
      • Austin Heart
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Cardiovascular Associates, Ltd
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Wausau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-point pacing arm; MultiPoint Pacing	Device: MultiPoint Pacing; Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
Active Comparator: Biventricular arm; Traditional Biventricular Pacing	Device: Traditional Biventricular Pacing; Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion	A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.	Implant to 9 months
Percentage of Non-responders With MPP Compared to Biventricular Pacing	The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below: Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation; Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation.; Unchanged - patient was neither improved nor worsened For patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders.	3 months to 9 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 60029161/D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study results will be presented at HRS Late-Breaking Clincial Trials Session in May, 2016