Clinical trial NCT00990665: Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
Official title: Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: CRT
Heart Failure
LV Leads
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 178
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 objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.


Eligibility criteria: Inclusion Criteria:

* Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
* Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
* 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

Exclusion Criteria:

* Have had a recent CVA or TIA within three months of enrollment
* Have a contraindication for an emergency thoracotomy
* Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
* Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
* Have undergone a cardiac transplantation within 40 days of enrollment
* Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
* Are currently participating in a clinical investigation that includes an active treatment arm
* Are pregnant or planning to become pregnant during the duration of the study
* Have a life expectancy of less than 6 months due to any condition
* Are less than 18 years of age
* Are unable to comply with the follow up schedule

Primary outcomes:
measure: Freedom From Left Ventricular Lead-Related Complications Through 3 Months
timeFrame: 3 months
measure: Freedom From System-related Complications Through 3 Months
timeFrame: 3 Months
measure: The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Baptist Health Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Glendale
country: United States
facility: Glendale Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Mountain View
country: United States
facility: ACS Research Group
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: San Diego
country: United States
facility: Scripps Green Hospital
state: California
city: Orlando
country: United States
facility: Orlando Heart Center
state: Florida
city: Saint Petersburg
country: United States
facility: The Heart and Vascular Institute of Florida - S. Pinellas
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Burlington
country: United States
facility: Lahey Clinical Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic Cardiovascular Healthcare Foundation
state: Michigan
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Elyria
country: United States
facility: EMH Regional Medical Center
state: Ohio
city: Lancaster
country: United States
facility: Lancaster Heart Foundation
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Milwaukee
country: United States
facility: Arrhythmia Center for Southern Wisconsin
state: Wisconsin
Study officials:
affiliation: Central Baptist Hospital
name: Gery Tomassoni, MD
role: STUDY_CHAIR
References:
citation: Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote(R) Q CRT-D and Quartet(R) Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet(R) left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22.