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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Quartet 1457Q LV Lead

• Registration Number: NCT02548455
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Study Start: 2015-10-27
• Primary Completion: 2016-08-19
• Study Completion: 2017-03-21
• Results First Submitted: 2018-04-05
• Results First Submitted QC: 2018-04-05
• Results First Posted: 2018-05-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Quartet 1457Q LV Lead	Subjects implanted with the Quartet 1457Q LV lead

Primary Outcome Measures

Name	Time	Method
Number of Patients Free From LV Lead-related Complications Through 3 Months	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.

Trial Locations

Locations (30)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Swedish Medical Center - Heart & Vascular; 🇺🇸 Seattle, Washington, United States

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

Lancaster General Hospital; 🇺🇸 Lancaster, Pennsylvania, United States

Cardiology Associates of Northeast Arkansas; 🇺🇸 Jonesboro, Arkansas, United States

Premier Cardiology, Inc.; 🇺🇸 Newport Beach, California, United States

One Health Cardiology; 🇺🇸 Owensboro, Kentucky, United States

Thoracic Cardiovascular Healthcare Foundation; 🇺🇸 Lansing, Michigan, United States

Erlanger Medical Center; 🇺🇸 Chattanooga, Tennessee, United States

Heart Center Research; 🇺🇸 Huntsville, Alabama, United States

Arizona Arrhythmia Research Center; 🇺🇸 Phoenix, Arizona, United States

Scripps Health; 🇺🇸 La Jolla, California, United States

Stanford University Hospital; 🇺🇸 Stanford, California, United States

Tallahassee Research Institute; 🇺🇸 Tallahassee, Florida, United States

Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

North Georgia Heart Foundation; 🇺🇸 Gainesville, Georgia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Missouri Heart Center; 🇺🇸 Columbia, Missouri, United States

Cardiovascular Associates of Delaware Valley; 🇺🇸 Haddon Heights, New Jersey, United States

Catholic Medical Center; 🇺🇸 Manchester, New Hampshire, United States

Oklahoma Heart Institute at Utica; 🇺🇸 Tulsa, Oklahoma, United States

Donald Guthrie Foundation for Education & Research; 🇺🇸 Sayre, Pennsylvania, United States

The Heart Hospital Baylor Plano; 🇺🇸 Plano, Texas, United States

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States

The Stern Cardiovascular Foundation; 🇺🇸 Germantown, Tennessee, United States

Central Baptist Hospital; 🇺🇸 Lexington, Kentucky, United States

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

St. Mary's Hospital; 🇺🇸 Madison, Wisconsin, United States

Munroe Regional Medical Center; 🇺🇸 Ocala, Florida, United States