MultiPoint Pacing IDE Study (MPP IDE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01786993
First received: February 6, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with multi-point pacing compared to patient treatment with standard Biventricular 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 patients implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.


Condition Intervention Phase
Heart Failure
Device: MultiPoint Pacing
Device: Traditional Biventricular Pacing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MultiPoint Pacing IDE Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from system-related complications [ Time Frame: 9-Month ] [ Designated as safety issue: Yes ]
  • Percentage of non-responders with multi-point pacing compared to biventricular pacing [ Time Frame: 9-Month ] [ Designated as safety issue: No ]

Estimated Enrollment: 506
Study Start Date: July 2014
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi-point pacing arm
MultiPoint Pacing
Device: MultiPoint Pacing
Active Comparator: Biventricular arm
Traditional Biventricular Pacing
Device: Traditional Biventricular Pacing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786993

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01786993     History of Changes
Other Study ID Numbers: 60029161/D
Study First Received: February 6, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014