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

Heart Failure Clinical Trial

Official title:

A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548455
• Other study ID #: CRD 616
• Status: Completed
• Phase: N/A
• Start date: October 27, 2015
• Est. completion date: March 21, 2017

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: March 21, 2017
• Est. primary completion date: August 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Quartet 1457Q LV Lead

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Missouri Heart Center	Columbia	Missouri
United States	North Georgia Heart Foundation	Gainesville	Georgia
United States	The Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Greenville Health System	Greenville	South Carolina
United States	Cardiovascular Associates of Delaware Valley	Haddon Heights	New Jersey
United States	Heart Center Research	Huntsville	Alabama
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	Scripps Health	La Jolla	California
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Thoracic Cardiovascular Healthcare Foundation	Lansing	Michigan
United States	Central Baptist Hospital	Lexington	Kentucky
United States	St. Mary's Hospital	Madison	Wisconsin
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Premier Cardiology, Inc.	Newport Beach	California
United States	Munroe Regional Medical Center	Ocala	Florida
United States	One Health Cardiology	Owensboro	Kentucky
United States	Arizona Arrhythmia Research Center	Phoenix	Arizona
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Donald Guthrie Foundation for Education & Research	Sayre	Pennsylvania
United States	Swedish Medical Center - Heart & Vascular	Seattle	Washington
United States	Stanford University Hospital	Stanford	California
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Oklahoma Heart Institute at Utica	Tulsa	Oklahoma
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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