MultiPoint Pacing IDE Study

NCT ID: NCT01786993

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 506 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-06-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multi-point pacing arm

MultiPoint Pacing

Group Type: EXPERIMENTAL

MultiPoint Pacing

Intervention Type: 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.

Biventricular arm

Traditional Biventricular Pacing

Group Type: ACTIVE_COMPARATOR

Traditional Biventricular Pacing

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Traditional Biventricular Pacing

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gery Tomassoni, MD

Role: PRINCIPAL_INVESTIGATOR

Central Baptist Hospital

Locations

Heart Center Research, LLC.

Huntsville, Alabama, United States

Banner Heart Hospital

Mesa, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Glendale Memorial Hospital and Medical Center

Glendale, California, United States

Scripps Green Hospital

La Jolla, California, United States

Premier Cardiology, Inc

Newport Beach, California, United States

Regional Cardiology Associates

Sacramento, California, United States

Sutter Memorial Hospital

Sacramento, California, United States

Colorado Heart & Vascular, P.C.

Lakewood, Colorado, United States

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, United States

Christiana Hospital

Newark, Delaware, United States

Bay Area Cardiology Associates PA

Brandon, Florida, United States

Watson Clinic Center

Lakeland, Florida, United States

Florida Hospital Orlando

Orlando, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

St. Joseph's Hospital

Atlanta, Georgia, United States

HeartCare Midwest

Peoria, Illinois, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Thoracic Cardio Healthcare Foundation

Lansing, Michigan, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Mercy Hospital St. Louis

St Louis, Missouri, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

New Mexico Heart Institute

Albuquerque, New Mexico, United States

New York Presbyterian Hospital/Cornell University

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, United States

Wake Forest University Medical Center Clinical Sciences

Winston-Salem, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

The Toledo Hospital

Toledo, Ohio, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

WellSpan Health

York, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

St. Thomas Hospital

Nashville, Tennessee, United States

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, United States

Cardiology Center of Amarillo, L.L.P

Amarillo, Texas, United States

Austin Heart

Austin, Texas, United States

South Texas Cardiovascular Consultants

San Antonio, Texas, United States

Cardiovascular Associates, LTD

Virginia Beach, Virginia, United States

Aurora Medical Group

Milwaukee, Wisconsin, United States

Aspirus Wausau Hospital

Wausau, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33028082 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29759832 (View on PubMed)

Other Identifiers

60029161/D

Identifier Type: -

Identifier Source: org_study_id