Clinical trial NCT02548455: Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
Official title: A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients Free From LV Lead-related Complications Through 3 Months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of Northeast Arkansas
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Newport Beach
country: United States
facility: Premier Cardiology, Inc.
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Gainesville
country: United States
facility: North Georgia Heart Foundation
state: Georgia
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Owensboro
country: United States
facility: One Health Cardiology
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic Cardiovascular Healthcare Foundation
state: Michigan
city: Columbia
country: United States
facility: Missouri Heart Center
state: Missouri
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of Delaware Valley
state: New Jersey
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute at Utica
state: Oklahoma
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education & Research
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center - Heart & Vascular
state: Washington
city: Madison
country: United States
facility: St. Mary's Hospital
state: Wisconsin
Study officials:
affiliation: Emory University
name: David Delurgio, MD
role: STUDY_CHAIR
References: