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Heart FailureQuad PASNCT01555619

Quadripolar Pacing Post Approval Study

An observational study of Heart Failure, run by Abbott Medical Devices at 71 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
CRT-D System
Type of treatment
Medical device
How many people
1,971 participants
Where
71 sitesUnited States
Study dates
15 Feb 2012to 28 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients indicated for CRT.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

71 sites in 1 country.

71 sites in 1 country

United States71 sites

  • Albany Medical College at Albany Medical Center

    Albany, New York, 12208

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

  • Piedmont Heart Institue

    Atlanta, Georgia, 30309

  • Florida Electrophysiology Associates

    Atlantis, Florida, 33462

  • Comprehensive Cardiovascular

    Bakersfield, California, 93309

  • MedStar Health Research Institute

    Baltimore, Maryland, 21237

  • Northeast Cardiology Associates

    Bangor, Maine, 04401

  • HeartPlace

    Bedford, Texas, 76021

  • Cardiology, P.C.

    Birmingham, Alabama, 35211

  • Yoel R. Vivas, MD

    Boynton Beach, Florida, 33437

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Bryn Mawr Medical Specialists Associates

    Bryn Mawr, Pennsylvania, 19010

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Unity Point Clinic

    Cedar Rapids, Iowa, 52403

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Cardiology Associatesof Corpus Christi

    Corpus Christi, Texas, 78404

  • Sinai Grace Hospital

    Detroit, Michigan, 48235

  • EMH Regional Medical Center

    Elyria, Ohio, 44035

  • Saint Vincent Consultants in Cardiovascular Diseases

    Erie, Pennsylvania, 16502

  • Sanford Research

    Fargo, North Dakota, 58122

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • Pee Dee Cardiology Associates, PA

    Florence, South Carolina, 29506

  • Parkview Research Center

    Fort Wayne, Indiana, 46805

  • Caromount Heart

    Gastonia, North Carolina, 28054

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035

  • Harrisonburg Medical Associations, Inc.

    Harrisonburg, Virginia, 22801

  • Houston Arrhythmia Associates

    Houston, Texas, 77024

  • Heart Center Research, LLC/Research Center

    Huntsville, Alabama, 35801

  • Cardiology Consultants

    Johnson City, Tennessee, 37601

  • Cardiovascular Associates, PC

    Kingsport, Tennessee, 37660

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Jorge Diaz

    Lake Mary, Florida, 32746

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17603

  • Thoracic Cardio Healthcare Foundation

    Lansing, Michigan, 48910

  • Cardiovascular Consultants of Nevada

    Las Vegas, Nevada, 89109

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • USC Unversity Hospital

    Los Angeles, California, 90033

  • Arrythmia Consultants, P.C.

    Memphis, Tennessee, 38104

  • The International Heart Institute of Montana

    Missoula, Montana, 59802

  • Southeastern Cardiology Consultants PC

    Montgomery, Alabama, 36116

  • Morgantown Internal Medicine Group, Inc.

    Morgantown, West Virginia, 26505

  • Fogarty Institute

    Mountain View, California, 94040

  • Northwest Indiana CardiovascularPhysicians, P.C.

    Munster, Indiana, 46321

  • Naples Heart Rhythm Specialists

    Naples, Florida, 34102

  • St. Thomas Hospital

    Nashville, Tennessee, 37205

  • Premier Cardiology, Inc.

    Newport Beach, California, 92663

  • Cardiac Rhythm Specialists, Inc.

    Northridge, California, 91325

  • Munroe Regional Medical Center

    Ocala, Florida, 34471

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Heart Consultants P.C.

    Omaha, Nebraska, 68122

  • St. Joseph Heritage Medical Group

    Orange, California, 92868

  • HeartCare Midwest

    Peoria, Illinois, 61614

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85006

  • Florida Heart Rhythm Specialists, LLC

    Plantation, Florida, 33324

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23229

  • Shady Grove Adventist Hospital

    Rockville, Maryland, 20850

  • Regional Cardiology Associates

    Sacramento, California, 95819

  • Medicine School of University Health Care

    Salt Lake City, Utah, 84132

  • Heart Clinics Northwest

    Spokane, Washington, 99204

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Northside Hospital

    St. Petersburg, Florida, 33709

  • St. Joseph's Medical Center

    Stockton, California, 95204

  • Stonybrook University Medical Center

    Stony Brook, New York, 11794

  • Cardiology Associates Medical Group, Inc.

    Ventura, California, 93003

  • Aspirius Heart and Vascular Institute, Research and Education

    Wausau, Wisconsin, 54401

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Buffalo Cardiology & Pulmonary Association

    Williamsville, New York, 14221

Other trials in United States

About this study

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).

Read the detailed description

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
Heart Failure
Being tested
CRT-D System
Keywords
Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart Failure, Quadripolar pacing
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRT-D SystemDevice

    Also called CRT-D and LV pacing lead

    Implantation of a CRT-D System

Study groups in NCT01555619
Study groupRoleWhat they receive
CRT-D SystemSt. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.
Receives: Device: CRT-D System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 years

  2. Complication free survival rate related to the LV lead

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

    Measured: 5 years

  3. Mean programmed LV lead pacing capture threshold

    Mean programmed LV lead pacing capture threshold at 5 years

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2012 (estimated)
  2. Study start15 Feb 2012
  3. Primary completion28 Feb 2019
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,971 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01555619
Sponsor's protocol ID
60030283
Acronym
Quad PAS
Status last verified
Apr 2019
First submitted
13 Mar 2012
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Abbott Medical Devices at 71 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complication free survival rate related to the CRT-D system (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01555619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019; AzTrials last refreshed its copy on 30 Oct 2026.

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