Clinical trial NCT00746356: Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
Official title: A Clinical Evaluation of the Current™ Radio Frequency (RF) Implantable Cardioverter Defibrillator (ICD) Models 2215/1215 and Promote™ RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) Model 3215 Pulse Generators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Ventricular Arrythmias
Keywords: heart failure
cardiac resynchronization therapy
autocapture
Current RF
Promote RF
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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, the patient's device will be programmed to turn that feature on. 3 months after enrollment, the patient will return to the clinic to have their device re-tested using an automatic test method to measure the amount of energy needed to make the patient's heart beat. A manual test method will also be used to measure the amount of energy needed to make the patient's heart beat. The intent of the study is to show the automatic method works just as well as the manual method.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Free of System-related Complications at 3-months Post Implant
timeFrame: 3 months post implant
measure: Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test
timeFrame: 3 months post implant
measure: Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test
timeFrame: 3 months post implant
measure: Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test
timeFrame: 3 months post implant
measure: Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test
timeFrame: 3 months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkanasas Heart Hospital
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Health Hospital
state: Arkansas
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: San Antonio
country: United States
facility: Southwest Texas Methodist Hospital
state: Texas
Study officials:
affiliation: Director, Clinical Affairs, St. Jude Medical
name: Tamara Shipman
role: STUDY_DIRECTOR
References: