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Trial record 1 of 3 for:    Quadripolar Pacing Post Approval Study
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Quadripolar Pacing Post Approval Study (Quad PAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01555619
First received: March 13, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The purpose of this post approval study is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy.


Condition Intervention
Heart Failure
Device: Implantation of a CRT-D System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quadripolar Pacing Post Approval Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • •Complication free survival rate through 5 years for complications related to the CRT-D system [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • •Complication free survival rate at 5 years for complications related to the left ventricular lead [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Mean programmed LV lead pacing capture threshold at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1884
Study Start Date: February 2012
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CRT-D System
St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.
Device: Implantation of a CRT-D System
Implantation of a CRT-D System
Other Name: CRT-D and LV pacing lead

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients indicated for cardiac resynchronization therapy.

Criteria

Inclusion Criteria:

  1. Approved indication per current ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s).
  2. Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study (IDE study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
  3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  1. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
  2. Have a life expectancy of less than 5 years due to any condition
  3. Be 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: NCT01555619

  Hide Study Locations
Locations
United States, Alabama
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
Heart Center Research, LLC/Research Center
Huntsville, Alabama, United States, 35801
Southeastern Cardiology Consultants PC
Montgomery, Alabama, United States, 36116
United States, Arizona
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States, 85006
United States, Arkansas
Washington Regional Medical Center
Fayetteville, Arkansas, United States, 72703
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
Comprehensive Cardiovascular
Bakersfield, California, United States, 93309
Scripps Green Hospital
La Jolla, California, United States, 92037
USC Unversity Hospital
Los Angeles, California, United States, 90033
Fogarty Institute
Mountain View, California, United States, 94040
Premier Cardiology, Inc.
Newport Beach, California, United States, 92663
Cardiac Rhythm Specialists, Inc.
Northridge, California, United States, 91325
St. Joseph Heritage Medical Group
Orange, California, United States, 92868
Regional Cardiology Associates
Sacramento, California, United States, 95819
St. Joseph's Medical Center
Stockton, California, United States, 95204
Cardiology Associates Medical Group, Inc.
Ventura, California, United States, 93003
United States, Florida
Florida Electrophysiology Associates
Atlantis, Florida, United States, 33462
Yoel R. Vivas, MD
Boynton Beach, Florida, United States, 33437
Jorge Diaz
Lake Mary, Florida, United States, 32746
Naples Heart Rhythm Specialists
Naples, Florida, United States, 34102
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
Florida Heart Rhythm Specialists, LLC
Plantation, Florida, United States, 33324
The Heart and Vascular Institute of Florida - S. Pinellas
St. Petersburg, Florida, United States, 33709
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Piedmont Heart Institue
Atlanta, Georgia, United States, 30309
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Illinois
HeartCare Midwest
Peoria, Illinois, United States, 61614
United States, Indiana
Parkview Research Center
Ft. Wayne, Indiana, United States, 46805
Northwest Indiana CardiovascularPhysicians, P.C.
Munster, Indiana, United States, 46321
United States, Iowa
Cardiologists, L.C.
Cedar Rapids, Iowa, United States, 52403
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Maine
Northeast Cardiology Associates
Bangor, Maine, United States, 04401
United States, Maryland
MedStar Health Research Institute
Baltimore, Maryland, United States, 21237
Shady Grove Adventist Hospital
Rockville, Maryland, United States, 20850
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
Sinai Grace Hospital
Detroit, Michigan, United States, 48235
Thoracic Cardio Healthcare Foundation
Lansing, Michigan, United States, 48910
United States, Missouri
Missouri Baptist Medical Center
St.Louis, Missouri, United States, 63131
United States, Montana
The International Heart Institute of Montana
Missoula, Montana, United States, 59802
United States, Nebraska
Heart Consultants P.C.
Omaha, Nebraska, United States, 68122
United States, Nevada
Cardiovascular Consultants of Nevada
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States, 08035
United States, New Mexico
Presbyterian Heart Group
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany Medical College at Albany Medical Center
Albany, New York, United States, 12208
Stonybrook University Medical Center
Stonybrook, New York, United States, 11794
Buffalo Cardiology & Pulmonary Association
Williamsville, New York, United States, 14221
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Caromount Heart
Gastonia, North Carolina, United States, 28054
United States, North Dakota
Sanford Research
Fargo, North Dakota, United States, 58122
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
EMH Regional Medical Center
Elyria, Ohio, United States, 44035
United States, Oklahoma
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Bryn Mawr Medical Specialists Associates
Bryn Mawr, Pennsylvania, United States, 19010
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania, United States, 16502
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17603
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Pee Dee Cardiology Associates, PA
Florence, South Carolina, United States, 29506
United States, Tennessee
Cardiology Consultants
Johnson City, Tennessee, United States, 37601
Cardiovascular Associates, PC
Kingsport, Tennessee, United States, 37660
Arrythmia Consultants, P.C.
Memphis, Tennessee, United States, 38104
St. Thomas Hospital
Nashville, Tennessee, United States, 37205
United States, Texas
HeartPlace
Bedford, Texas, United States, 76021
Cardiology Associatesof Corpus Christi
Corpus Christi, Texas, United States, 78404
Houston Arrhythmia Associates
Houston, Texas, United States, 77024
United States, Utah
Medicine School of University Health Care
Salt Lake City, Utah, United States, 84132
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Harrisonburg Medical Associations, Inc.
Harrisonburg, Virginia, United States, 22801
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23229
United States, Washington
Heart Clinics Northwest
Spokane, Washington, United States, 99204
United States, West Virginia
Morgantown Internal Medicine Group, Inc.
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Aspirius Heart and Vascular Institute, Research and Education
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Raffaele Corbisiero, MD Deborah Heart and Lung Center
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01555619     History of Changes
Other Study ID Numbers: 60030283
Study First Received: March 13, 2012
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
Left heart pacing lead
Cardiac resynchronization therapy (CRT)
Heart Failure
Quadripolar pacing

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014