Quadripolar Pacing Post Approval Study (Quad PAS)

April 12, 2019 updated by: Abbott Medical Devices
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so.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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1971

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for CRT.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CRT-D System
St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.
Device: CRT-D System
Implantation of a CRT-D System
Other Names:
  • CRT-D and LV pacing lead

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complication free survival rate related to the CRT-D system
Time Frame: 5 years
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
Time Frame: 5 years
Complication free survival rate at 5 years for complications related to the LV lead
5 years
Mean programmed LV lead pacing capture threshold
Time Frame: 5 years
Mean programmed LV lead pacing capture threshold at 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Raffaele Corbisiero, MD, Deborah Heart and Lung Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 60030283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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