Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds

Completed · Not applicable

Conditions studied: Heart Failure, Ventricular Arrythmias

In brief

This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices. These new ICD and CRT-D devices have new features that allow the device to periodically check how much energy is needed to pace a patient's heart and to automatically adjust the amount of energy used to pace the heart.

Key facts

Study ID

NCT00746356

Run by

Abbott Medical Devices

People needed

128

Starts

2008-08-01

Expected to finish

2010-01-01

Last updated by the study team

2019-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have an approved indication, as outlined by American Heart Association/Heart Rhythm Society (AHA/HRS) guidelines, for implantation of an ICD or CRT-D for the treatment of life-threatening ventricular tachyarrhythmia(s) or heart failure, or undergo revision of their ICD or CRT-D system to replace the pulse generator.
• Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

You may not qualify if…

• Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months.
• Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA), Stent or Coronary Artery Bypass Graft(CABG)) within 40 days of enrollment.
• Have had a recent cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment.
• Are allergic to dexamethasone sodium phosphate (DSP).
• Be currently participating in a clinical investigation that includes an active treatment arm.
• Be pregnant or are planning for pregnancy within 6 months following enrollment.
• Have a life expectancy of less than 6 months.
• Be less than 18 years of age.

Where it is running

• Arkanasas Heart Hospital — Little Rock, Arkansas, United States
• Baptist Health Hospital — Little Rock, Arkansas, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• St. Thomas Hospital — Nashville, Tennessee, United States
• Southwest Texas Methodist Hospital — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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