Quadripolar Pacing Post Approval Study

NCT ID: NCT01555619

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1971 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-15

Study Completion Date

2019-02-28

Brief Summary

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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 (CRT).

Detailed Description

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Quad PAS is a multi-center, post-approval study. Patients who meet inclusion/exclusion criteria will have an attempted implant of a Quadripolar CRT-D device system (device and left ventricular (LV) lead). Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so. Patients enrolled in the study will be followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years). After patients complete 60 months of follow-up, their participation in the study will be terminated.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CRT-D System

St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.

CRT-D System

Intervention Type DEVICE

Implantation of a CRT-D System

Interventions

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CRT-D System

Implantation of a CRT-D System

Intervention Type DEVICE

Other Intervention Names

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CRT-D and LV pacing lead

Eligibility Criteria

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Inclusion Criteria

1. Approved indication per current American College of Cardiology/American Heart Association/Heart Rhythm Society 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 (Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing implantable cardioverter-defibrillator 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raffaele Corbisiero, MD

Role: STUDY_CHAIR

Deborah Heart and Lung Center

Locations

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Cardiology, P.C.

Birmingham, Alabama, United States

Site Status

Heart Center Research, LLC/Research Center

Huntsville, Alabama, United States

Site Status

Southeastern Cardiology Consultants PC

Montgomery, Alabama, United States

Site Status

Arizona Arrhythmia Research Center

Phoenix, Arizona, United States

Site Status

Washington Regional Medical Center

Fayetteville, Arkansas, United States

Site Status

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status

Comprehensive Cardiovascular

Bakersfield, California, United States

Site Status

Scripps Green Hospital

La Jolla, California, United States

Site Status

USC Unversity Hospital

Los Angeles, California, United States

Site Status

Fogarty Institute

Mountain View, California, United States

Site Status

Premier Cardiology, Inc.

Newport Beach, California, United States

Site Status

Cardiac Rhythm Specialists, Inc.

Northridge, California, United States

Site Status

St. Joseph Heritage Medical Group

Orange, California, United States

Site Status

Regional Cardiology Associates

Sacramento, California, United States

Site Status

St. Joseph's Medical Center

Stockton, California, United States

Site Status

Cardiology Associates Medical Group, Inc.

Ventura, California, United States

Site Status

Florida Electrophysiology Associates

Atlantis, Florida, United States

Site Status

Yoel R. Vivas, MD

Boynton Beach, Florida, United States

Site Status

Jorge Diaz

Lake Mary, Florida, United States

Site Status

Naples Heart Rhythm Specialists

Naples, Florida, United States

Site Status

Munroe Regional Medical Center

Ocala, Florida, United States

Site Status

Florida Heart Rhythm Specialists, LLC

Plantation, Florida, United States

Site Status

Northside Hospital

St. Petersburg, Florida, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Piedmont Heart Institue

Atlanta, Georgia, United States

Site Status

HeartCare Midwest

Peoria, Illinois, United States

Site Status

Parkview Research Center

Fort Wayne, Indiana, United States

Site Status

Northwest Indiana CardiovascularPhysicians, P.C.

Munster, Indiana, United States

Site Status

Unity Point Clinic

Cedar Rapids, Iowa, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

Northeast Cardiology Associates

Bangor, Maine, United States

Site Status

MedStar Health Research Institute

Baltimore, Maryland, United States

Site Status

Shady Grove Adventist Hospital

Rockville, Maryland, United States

Site Status

Lahey Clinic

Burlington, Massachusetts, United States

Site Status

Sinai Grace Hospital

Detroit, Michigan, United States

Site Status

Thoracic Cardio Healthcare Foundation

Lansing, Michigan, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

The International Heart Institute of Montana

Missoula, Montana, United States

Site Status

Heart Consultants P.C.

Omaha, Nebraska, United States

Site Status

Cardiovascular Consultants of Nevada

Las Vegas, Nevada, United States

Site Status

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Site Status

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, United States

Site Status

Presbyterian Heart Group

Albuquerque, New Mexico, United States

Site Status

Albany Medical College at Albany Medical Center

Albany, New York, United States

Site Status

Stonybrook University Medical Center

Stony Brook, New York, United States

Site Status

Buffalo Cardiology & Pulmonary Association

Williamsville, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Caromount Heart

Gastonia, North Carolina, United States

Site Status

Sanford Research

Fargo, North Dakota, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

EMH Regional Medical Center

Elyria, Ohio, United States

Site Status

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Bryn Mawr Medical Specialists Associates

Bryn Mawr, Pennsylvania, United States

Site Status

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, United States

Site Status

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Pee Dee Cardiology Associates, PA

Florence, South Carolina, United States

Site Status

Cardiology Consultants

Johnson City, Tennessee, United States

Site Status

Cardiovascular Associates, PC

Kingsport, Tennessee, United States

Site Status

Arrythmia Consultants, P.C.

Memphis, Tennessee, United States

Site Status

St. Thomas Hospital

Nashville, Tennessee, United States

Site Status

HeartPlace

Bedford, Texas, United States

Site Status

Cardiology Associatesof Corpus Christi

Corpus Christi, Texas, United States

Site Status

Houston Arrhythmia Associates

Houston, Texas, United States

Site Status

Medicine School of University Health Care

Salt Lake City, Utah, United States

Site Status

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Site Status

Harrisonburg Medical Associations, Inc.

Harrisonburg, Virginia, United States

Site Status

Virginia Cardiovascular Specialists

Richmond, Virginia, United States

Site Status

Heart Clinics Northwest

Spokane, Washington, United States

Site Status

Morgantown Internal Medicine Group, Inc.

Morgantown, West Virginia, United States

Site Status

Aspirius Heart and Vascular Institute, Research and Education

Wausau, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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60030283

Identifier Type: -

Identifier Source: org_study_id

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