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MultiPoint Pacing IDE Study (MPP IDE)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MultiPoint Pacing
Traditional Biventricular Pacing
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center Research, LLC.
  • Banner Heart Hospital
  • Arkansas Heart Hospital
  • Glendale Memorial Hospital and Medical Center
  • Scripps Green Hospital
  • Premier Cardiology, Inc
  • Regional Cardiology Associates
  • Sutter Memorial Hospital
  • Colorado Heart & Vascular, P.C.
  • Cardiology Associates of Fairfield County, PC
  • Christiana Hospital
  • Bay Area Cardiology Associates PA
  • Watson Clinic Center
  • Florida Hospital Orlando
  • Sarasota Memorial Hospital
  • St. Joseph's Hospital
  • HeartCare Midwest
  • Central Baptist Hospital
  • Ochsner Medical Center
  • Lahey Clinic Medical Center
  • Thoracic Cardio Healthcare Foundation
  • Jackson Heart Clinic
  • North Mississippi Medical Center
  • St. Luke's Hospital
  • Mercy Hospital St. Louis
  • Deborah Heart and Lung Center
  • Englewood Hospital and Medical Center
  • Morristown Memorial Hospital
  • New Mexico Heart Institute
  • New York Presbyterian Hospital/Cornell University
  • University of Rochester Medical Center
  • Novant Health Heart and Vascular Research Institute
  • Wake Forest University Medical Center Clinical Sciences
  • The Cleveland Clinic Foundation
  • Ohio Health Research Institute
  • The Toledo Hospital
  • Lancaster General Hospital
  • Thomas Jefferson University Hospital
  • University of Pittsburgh Medical Center
  • WellSpan Health
  • Medical University of South Carolina
  • St. Thomas Hospital
  • Vanderbilt Heart and Vascular Institute
  • Cardiology Center of Amarillo, L.L.P
  • Austin Heart
  • South Texas Cardiovascular Consultants
  • Cardiovascular Associates, LTD
  • Aurora Medical Group
  • Aspirus Wausau Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multi-point pacing arm

Biventricular arm

Arm Description

MultiPoint Pacing

Traditional Biventricular Pacing

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2013
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01786993
Brief Title
MultiPoint Pacing IDE Study
Acronym
MPP IDE
Official Title
MultiPoint Pacing IDE Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
506 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-point pacing arm
Arm Type
Experimental
Arm Description
MultiPoint Pacing
Arm Title
Biventricular arm
Arm Type
Active Comparator
Arm Description
Traditional Biventricular Pacing
Intervention Type
Device
Intervention Name(s)
MultiPoint Pacing
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional Biventricular Pacing
Intervention Description
Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
Primary Outcome Measure Information:
Title
Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion
Description
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.
Time Frame
Implant to 9 months
Title
Percentage of Non-responders With MPP Compared to Biventricular Pacing
Description
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.
Time Frame
3 months to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gery Tomassoni, MD
Organizational Affiliation
Central Baptist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research, LLC.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Banner Heart Hospital
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Glendale Memorial Hospital and Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Premier Cardiology, Inc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Sutter Memorial Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Colorado Heart & Vascular, P.C.
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Cardiology Associates of Fairfield County, PC
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Bay Area Cardiology Associates PA
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Watson Clinic Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
HeartCare Midwest
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Thoracic Cardio Healthcare Foundation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Jackson Heart Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New York Presbyterian Hospital/Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Novant Health Heart and Vascular Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Wake Forest University Medical Center Clinical Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43124
Country
United States
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
WellSpan Health
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt Heart and Vascular Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Cardiology Center of Amarillo, L.L.P
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
South Texas Cardiovascular Consultants
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Cardiovascular Associates, LTD
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Aurora Medical Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study results will be presented at HRS Late-Breaking Clincial Trials Session in May, 2016
Citations:
PubMed Identifier
33028082
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.
Results Reference
derived
PubMed Identifier
29759832
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.
Results Reference
derived

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MultiPoint Pacing IDE Study

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