MultiPoint Pacing IDE Study

NCT01786993 | Completed Phase 3 Results

• 1 other identifier: 60029161/D
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 49

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Multi-point pacing arm

EXPERIMENTAL

MultiPoint Pacing

Device: MultiPoint Pacing

Biventricular arm

ACTIVE COMPARATOR

Traditional Biventricular Pacing

Device: Traditional Biventricular Pacing

Interventions

MultiPoint Pacing DEVICE

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.

Multi-point pacing arm

Traditional Biventricular Pacing DEVICE

Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.

Biventricular arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (49)

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Banner Heart Hospital

Mesa, Arizona, 85027, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Glendale Memorial Hospital and Medical Center

Glendale, California, 91206, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Premier Cardiology, Inc

Newport Beach, California, 92663, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95819, United States

Location

Colorado Heart & Vascular, P.C.

Lakewood, Colorado, 80228, United States

Location

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, 06851, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Bay Area Cardiology Associates PA

Brandon, Florida, 33511, United States

Location

Watson Clinic Center

Lakeland, Florida, 33805, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

HeartCare Midwest

Peoria, Illinois, 61614, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

Thoracic Cardio Healthcare Foundation

Lansing, Michigan, 48910, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, 28204, United States

Location

Wake Forest University Medical Center Clinical Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43124, United States

Location

The Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

WellSpan Health

York, Pennsylvania, 17403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Cardiology Center of Amarillo, L.L.P

Amarillo, Texas, 79106, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78201, United States

Location

Cardiovascular Associates, LTD

Virginia Beach, Virginia, 23454, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Related Publications (2)

• 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.

  PMID: 33028082 DERIVED

• 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.

  PMID: 29759832 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Director of Clinical Studies
• Organization: St. Jude Medical

ccohorn@sjm.com

972-309-8000

Study Officials

• Gery Tomassoni, MD

  Central Baptist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 4, 2019
• Results First Posted: September 30, 2016

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

US (49)