Quadripolar Pacing Post Approval Study

NCT01555619 | Completed FDA Device

• 1 other identifier: 60030283
• Study Type: observational
• Target: 1,971
• Locations: 1 country
• Sites: 71

Brief Summary

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).

Conditions

Heart Failure

Keywords

Left heart pacing lead; Cardiac resynchronization therapy (CRT); Heart Failure; Quadripolar pacing

Outcome Measures

Primary Outcomes (3)

• Complication free survival rate related to the CRT-D system

  Complication free survival rate through 5 years for complications related to the CRT-D system

  5 years

• Complication free survival rate related to the LV lead

  Complication free survival rate at 5 years for complications related to the LV lead

  5 years

• Mean programmed LV lead pacing capture threshold

  Mean programmed LV lead pacing capture threshold at 5 years

  5 years

Study Arms (1)

CRT-D System

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

Device: CRT-D System

Interventions

CRT-D System DEVICE

Implantation of a CRT-D System

Also known as: CRT-D and LV pacing lead

CRT-D System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for CRT.

You may qualify if:

• 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).
• 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.
• 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

You may not qualify if:

• Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
• Have a life expectancy of less than 5 years due to any condition
• Be less than 18 years of age

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (71)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

Heart Center Research, LLC/Research Center

Huntsville, Alabama, 35801, United States

Location

Southeastern Cardiology Consultants PC

Montgomery, Alabama, 36116, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85006, United States

Location

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Comprehensive Cardiovascular

Bakersfield, California, 93309, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

USC Unversity Hospital

Los Angeles, California, 90033, United States

Location

Fogarty Institute

Mountain View, California, 94040, United States

Location

Premier Cardiology, Inc.

Newport Beach, California, 92663, United States

Location

Cardiac Rhythm Specialists, Inc.

Northridge, California, 91325, United States

Location

St. Joseph Heritage Medical Group

Orange, California, 92868, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

St. Joseph's Medical Center

Stockton, California, 95204, United States

Location

Cardiology Associates Medical Group, Inc.

Ventura, California, 93003, United States

Location

Florida Electrophysiology Associates

Atlantis, Florida, 33462, United States

Location

Yoel R. Vivas, MD

Boynton Beach, Florida, 33437, United States

Location

Jorge Diaz

Lake Mary, Florida, 32746, United States

Location

Naples Heart Rhythm Specialists

Naples, Florida, 34102, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Florida Heart Rhythm Specialists, LLC

Plantation, Florida, 33324, United States

Location

Northside Hospital

St. Petersburg, Florida, 33709, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Piedmont Heart Institue

Atlanta, Georgia, 30309, United States

Location

HeartCare Midwest

Peoria, Illinois, 61614, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46805, United States

Location

Northwest Indiana CardiovascularPhysicians, P.C.

Munster, Indiana, 46321, United States

Location

Unity Point Clinic

Cedar Rapids, Iowa, 52403, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Northeast Cardiology Associates

Bangor, Maine, 04401, United States

Location

MedStar Health Research Institute

Baltimore, Maryland, 21237, United States

Location

Shady Grove Adventist Hospital

Rockville, Maryland, 20850, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Sinai Grace Hospital

Detroit, Michigan, 48235, United States

Location

Thoracic Cardio Healthcare Foundation

Lansing, Michigan, 48910, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

The International Heart Institute of Montana

Missoula, Montana, 59802, United States

Location

Heart Consultants P.C.

Omaha, Nebraska, 68122, United States

Location

Cardiovascular Consultants of Nevada

Las Vegas, Nevada, 89109, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Presbyterian Heart Group

Albuquerque, New Mexico, 87106, United States

Location

Albany Medical College at Albany Medical Center

Albany, New York, 12208, United States

Location

Stonybrook University Medical Center

Stony Brook, New York, 11794, United States

Location

Buffalo Cardiology & Pulmonary Association

Williamsville, New York, 14221, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Caromount Heart

Gastonia, North Carolina, 28054, United States

Location

Sanford Research

Fargo, North Dakota, 58122, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

EMH Regional Medical Center

Elyria, Ohio, 44035, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Bryn Mawr Medical Specialists Associates

Bryn Mawr, Pennsylvania, 19010, United States

Location

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, 16502, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17603, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pee Dee Cardiology Associates, PA

Florence, South Carolina, 29506, United States

Location

Cardiology Consultants

Johnson City, Tennessee, 37601, United States

Location

Cardiovascular Associates, PC

Kingsport, Tennessee, 37660, United States

Location

Arrythmia Consultants, P.C.

Memphis, Tennessee, 38104, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

HeartPlace

Bedford, Texas, 76021, United States

Location

Cardiology Associatesof Corpus Christi

Corpus Christi, Texas, 78404, United States

Location

Houston Arrhythmia Associates

Houston, Texas, 77024, United States

Location

Medicine School of University Health Care

Salt Lake City, Utah, 84132, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Harrisonburg Medical Associations, Inc.

Harrisonburg, Virginia, 22801, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23229, United States

Location

Heart Clinics Northwest

Spokane, Washington, 99204, United States

Location

Morgantown Internal Medicine Group, Inc.

Morgantown, West Virginia, 26505, United States

Location

Aspirius Heart and Vascular Institute, Research and Education

Wausau, Wisconsin, 54401, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Raffaele Corbisiero, MD

  Deborah Heart and Lung Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: February 15, 2012
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (71)