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

NCT ID: NCT02548455

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 499 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-27
• Study Completion Date: 2017-03-21

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.

Detailed Description

This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.

A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.

All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Subjects implanted with the Quartet 1457Q LV lead

Group Type: EXPERIMENTAL

Quartet 1457Q LV Lead

Intervention Type: DEVICE

Interventions

Quartet 1457Q LV Lead

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.

3. 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.

4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria

1. Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt

2. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate

3. 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.

4. Are pregnant or planning pregnancy in the next 6 months

5. Have a life expectancy of less than 24 months due to any condition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Delurgio, MD

Role: STUDY_CHAIR

Emory University

Locations

Heart Center Research

Huntsville, Alabama, United States

Arizona Arrhythmia Research Center

Phoenix, Arizona, United States

Cardiology Associates of Northeast Arkansas

Jonesboro, Arkansas, United States

Scripps Health

La Jolla, California, United States

Premier Cardiology, Inc.

Newport Beach, California, United States

Stanford University Hospital

Stanford, California, United States

Munroe Regional Medical Center

Ocala, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

North Georgia Heart Foundation

Gainesville, Georgia, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Central Baptist Hospital

Lexington, Kentucky, United States

One Health Cardiology

Owensboro, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Thoracic Cardiovascular Healthcare Foundation

Lansing, Michigan, United States

Missouri Heart Center

Columbia, Missouri, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Cardiovascular Associates of Delaware Valley

Haddon Heights, New Jersey, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Donald Guthrie Foundation for Education & Research

Sayre, Pennsylvania, United States

Greenville Health System

Greenville, South Carolina, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

The Stern Cardiovascular Foundation

Germantown, Tennessee, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Swedish Medical Center - Heart & Vascular

Seattle, Washington, United States

St. Mary's Hospital

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

CRD 616

Identifier Type: -

Identifier Source: org_study_id