Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

Abbott

Status

Completed

Conditions

Heart Failure

Treatments

Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00990665

60024498/E

Details and patient eligibility

About

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.

Enrollment

178 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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