Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study

NCT02548455 | Completed Results FDA Device

• 1 other identifier: CRD 616
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 30

Brief Summary

The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of Patients Free From LV Lead-related Complications Through 3 Months

  A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.

  3 months

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects implanted with the Quartet 1457Q LV lead

Device: Quartet 1457Q LV Lead

Interventions

Quartet 1457Q LV Lead DEVICE

Treatment

Eligibility Criteria

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

You may qualify if:

• Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:
• " to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.
• Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
• Have the 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.
• Are 18 years or above, or of legal age to give informed consent specific to state and national law.

You may not qualify if:

• Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
• Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
• Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
• Are pregnant or planning pregnancy in the next 6 months
• Have a life expectancy of less than 24 months due to any condition

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (30)

Heart Center Research

Huntsville, Alabama, 35801, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85013, United States

Location

Cardiology Associates of Northeast Arkansas

Jonesboro, Arkansas, 72401, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Premier Cardiology, Inc.

Newport Beach, California, 92663, United States

Location

Stanford University Hospital

Stanford, California, 94305, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

North Georgia Heart Foundation

Gainesville, Georgia, 30501, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

One Health Cardiology

Owensboro, Kentucky, 42304, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Thoracic Cardiovascular Healthcare Foundation

Lansing, Michigan, 48912, United States

Location

Missouri Heart Center

Columbia, Missouri, 65201, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Cardiovascular Associates of Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, 74104, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Donald Guthrie Foundation for Education & Research

Sayre, Pennsylvania, 18840, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Swedish Medical Center - Heart & Vascular

Seattle, Washington, 98122, United States

Location

St. Mary's Hospital

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clay Cohorn, Clinical Program Director
• Organization: Abbott

clay.cohorn@abbott.com

972-309-8087

Study Officials

• David Delurgio, MD

  Emory University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 14, 2015
• Study Start: October 27, 2015
• Primary Completion: August 19, 2016
• Study Completion: March 21, 2017
• Last Updated: February 4, 2019
• Results First Posted: May 8, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)