Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study (Promote Q)

February 7, 2019 updated by: Abbott Medical Devices

Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

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, 35233
        • University Hospital of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Medical Center
    • California
      • Glendale, California, United States, 91204
        • Glendale Memorial Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Mountain View, California, United States, 94040
        • ACS Research Group
      • Sacramento, California, United States, 95819
        • Regional Cardiology Associates
      • San Diego, California, United States, 92037
        • Scripps Green Hospital
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Heart Center
      • Saint Petersburg, Florida, United States, 33705
        • The Heart and Vascular Institute of Florida - S. Pinellas
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
    • Illinois
      • Lombard, Illinois, United States, 60148
        • Midwest Heart Foundation
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinical Medical Center
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Thoracic Cardiovascular Healthcare Foundation
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Elyria, Ohio, United States, 44035
        • EMH Regional Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster Heart Foundation
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Arrhythmia Center for Southern Wisconsin

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
  • Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
  • Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  • Have had a recent CVA or TIA within three months of enrollment
  • Have a contraindication for an emergency thoracotomy
  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
  • Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
  • Have undergone a cardiac transplantation within 40 days of enrollment
  • Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
  • Are currently participating in a clinical investigation that includes an active treatment arm
  • Are pregnant or planning to become pregnant during the duration of the study
  • Have a life expectancy of less than 6 months due to any condition
  • Are less than 18 years of age
  • Are unable to comply with the follow up schedule

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRT-D and LV lead
Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Promote Q CRT-D and Quartet LV lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Left Ventricular Lead-Related Complications Through 3 Months
Time Frame: 3 months
The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
3 months
Freedom From System-related Complications Through 3 Months
Time Frame: 3 Months
The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
3 Months
The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.
Time Frame: 3 Months
The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).
3 Months

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: Gery Tomassoni, MD, Central Baptist Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (Estimate)

October 7, 2009

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60024498/E

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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