Status:
COMPLETED
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Ventricular Arrythmias
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. T...
Detailed Description
All patients enrolled in the study will have their device tested to determine if the device can automatically measure how much energy is needed to pace the patient's heart. If the test is successful, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00746356
Start Date
August 1 2008
End Date
January 1 2010
Last Update
February 19 2019
Active Locations (5)
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1
Arkanasas Heart Hospital
Little Rock, Arkansas, United States, 72211
2
Baptist Health Hospital
Little Rock, Arkansas, United States, 73305
3
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
4
St. Thomas Hospital
Nashville, Tennessee, United States, 37205