MultiPoint Pacing IDE Study (MPP IDE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01786993
First received: February 6, 2013
Last updated: April 22, 2014
Last verified: April 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

Resource links provided by NLM:


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: April 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 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

Contacts
Contact: Kwangdeok Lee, PhD 818-493-2522

  Hide Study Locations
Locations
United States, Alabama
Heart Center Research, LLC. Recruiting
Huntsville, Alabama, United States, 35801
Contact: Jay Dinerman, MD    256-519-8275      
Principal Investigator: Jay Dinerman, MD         
United States, Arkansas
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Scott L Beau, MD    501-664-5860      
Principal Investigator: Scott L Beau, MD         
United States, California
Glendale Memorial Hospital and Medical Center Recruiting
Glendale, California, United States, 91206
Contact: John P McKenzie, III, MD    818-502-9420      
Principal Investigator: John P McKenzie III, MD         
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Contact: Thomas Ahern, MD    858-554-5039      
Principal Investigator: Thomas Ahern, MD         
Premier Cardiology, Inc Recruiting
Newport Beach, California, United States, 92663
Contact: Rajesh Banker, MD    949-478-7373      
Principal Investigator: Rajesh Banker, MD         
Regional Cardiology Associates Recruiting
Sacramento, California, United States, 95819
Contact: Gearoid O'Neill, MD    916-736-2323      
Principal Investigator: Gearoid O'Neill, MD         
Sutter Memorial Hospital Recruiting
Sacramento, California, United States, 95819
Contact: Kyle Michaelis, MD    916-830-2000      
Principal Investigator: Kyle Michaelis, MD         
United States, Colorado
Colorado Heart & Vascular, P.C. Recruiting
Lakewood, Colorado, United States, 80228
Contact: Christopher Stees, MD    303-595-2727      
Principal Investigator: Christopher Stees, MD         
United States, Connecticut
Cardiology Associates of Fairfield County, PC Recruiting
Norwalk, Connecticut, United States, 06851
Contact: Joseph Tiano, MD    203-445-7093      
Principal Investigator: Joseph Tiano, MD         
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Roger Kerzner, MD    302-366-1929      
Principal Investigator: Roger Kerzner, MD         
United States, Florida
Bay Area Cardiology Associates PA Recruiting
Brandon, Florida, United States, 33511
Contact: Stephen W Mester, MD    813-684-6000      
Principal Investigator: Stephen W Mester, MD         
Watson Clinic Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Neal Kavesh, MD    863-860-7617      
Principal Investigator: Neal Kavesh, MD         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Scott Pollak, MD    407-841-7151      
Principal Investigator: Scott Pollak, MD         
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Michael Mumma, MD    941-917-0060      
Principal Investigator: Michael Mumma, MD         
United States, Georgia
St. Joseph's Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Anshul Patel, MD    770-757-6455      
Principal Investigator: Anshul Patel, MD         
United States, Illinois
HeartCare Midwest Recruiting
Peoria, Illinois, United States, 61614
Contact: Timir Baman, MD    309-691-4410      
Principal Investigator: Timir Baman, MD         
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Contact: Gery Tomassoni, MD    859-277-5887      
Principal Investigator: Gery Tomassoni, MD         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Sammy Khatib, MD    504-842-2372      
Principal Investigator: Sammy Khatib, MD         
United States, Massachusetts
Lahey Clinic Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Muqtada G Chaudhry, MD    781-744-8863      
Principal Investigator: Muqtada G Chaudhry, MD         
United States, Michigan
Thoracic Cardio Healthcare Foundation Recruiting
Lansing, Michigan, United States, 48910
Contact: John Ip, MD    517-483-7550      
Principal Investigator: John Ip, MD         
United States, Mississippi
Jackson Heart Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Judson Colley, MD    601-982-7850      
Principal Investigator: Judson Colley, MD         
North Mississippi Medical Center Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Keith Kyker, MD    662-620-6800      
Principal Investigator: Keith Kyker, MD         
United States, Missouri
St. Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Brian M Ramza, MD, PhD    816-931-1883      
Principal Investigator: Brian M Ramza, MD, PhD         
Mercy Hospital St. Louis Recruiting
St. Louis, Missouri, United States, 63141
Contact: Amit Doshi, MD    314-251-1700      
Principal Investigator: Amit Doshi, MD         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Raffaele Corbisiero, MD         
Principal Investigator: Raffaele Corbisiero, MD         
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: David Y Feigenblum, MD    201-894-3533      
Principal Investigator: David Y Feigenblum, MD         
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Timothy Mahoney, MD    973-971-4261      
Principal Investigator: Timothy Mahoney, MD         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Ross Downey, MD    505-841-1000      
Principal Investigator: Ross Downey, MD         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: David Huang, MD    585-273-7355      
Principal Investigator: David Huang, MD         
United States, North Carolina
Novant Health Heart and Vascular Research Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Kevin Hsu, MD    704-343-9800      
Principal Investigator: Kevin Hsu, MD         
Wake Forest University Medical Center Clinical Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Bryon E Rubery, MD    336-716-4673      
Principal Investigator: Bryon E Rubery, MD         
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Niraj Varma, MD    216-444-2142      
Principal Investigator: Niraj Varma, MD         
Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43124
Contact: Seth Rials, MD    614-566-8298      
Principal Investigator: Seth Rials, MD         
The Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Mark Richards, MD, PhD    419-842-3000      
Principal Investigator: Mark Richards, MD, PhD         
United States, Pennsylvania
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Seth J Worley, MD    717-397-5484      
Principal Investigator: Seth J Worley, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Reginald Ho, MD    215-955-8659      
Principal Investigator: Reginald Ho, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Samir Saba, MD    412-647-2762      
Principal Investigator: Samir Saba, MD         
WellSpan Health Recruiting
York, Pennsylvania, United States, 17403
Contact: Lyle A Siddoway, MD         
Principal Investigator: Lyle A Siddoway, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Michael Gold, MD, PhD         
Principal Investigator: Michael Gold, MD, PhD         
United States, Tennessee
Vanderbilt Heart and Vascular Institute Recruiting
Nashville, Tennessee, United States, 37232
Contact: Christopher Ellis, MD    615-936-1724      
Principal Investigator: Christopher Ellis, MD         
St. Thomas Hospital Recruiting
Nashville, Tennessee, United States, 37205
Contact: James Baker, MD         
Principal Investigator: James Baker, MD         
United States, Texas
Cardiology Center of Amarillo, L.L.P Recruiting
Amarillo, Texas, United States, 79106
Contact: Coty Jewell, MD         
Principal Investigator: Coty Jewell, MD         
Austin Heart Recruiting
Austin, Texas, United States, 78756
Contact: Kunjan Bhatt, MD    512-421-3860      
Principal Investigator: Kunjan Bhatt, MD         
South Texas Cardiovascular Consultants Recruiting
San Antonio, Texas, United States, 78201
Contact: Javier Roman Gonzalez, MD    210-692-1414      
Principal Investigator: Javier Roman Gonzalez, MD         
United States, Virginia
Cardiovascular Associates, LTD Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Lee Kanter, MD    757-419-3000      
Principal Investigator: Lee Kanter, MD         
United States, Wisconsin
Aurora Medical Group Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Imran Niazi, MD    414-385-6367      
Principal Investigator: Imran Niazi, MD         
Aspirus Wausau Hospital Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Kevin E Rist, MD    715-847-2611      
Principal Investigator: Kevin E Rist, MD         
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: April 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014