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

Purpose

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.

Condition	Intervention
Heart Failure Ventricular Arrythmias	Device: Testing of the autocapture features of the device

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia Heart Failure

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Percentage of Participants Free of System-related Complications at 3-months Post Implant [ Time Frame: 3 months post implant ] [ Designated as safety issue: Yes ]
Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test [ Time Frame: 3 months post implant ] [ Designated as safety issue: No ]
Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.
Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test [ Time Frame: 3 months post implant ] [ Designated as safety issue: No ]
Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.
Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test [ Time Frame: 3 months post implant ] [ Designated as safety issue: No ]
Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.
Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test [ Time Frame: 3 months post implant ] [ Designated as safety issue: No ]
Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.

Enrollment:	128
Study Start Date:	August 2008
Study Completion Date:	January 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Promote RF CRT-D Patients with CRT-D device will have the autocapture features of the device tested.	Device: Testing of the autocapture features of the device Patients receiving cardiac resynchronization therapy will have new autocapture features tested on right atrial, right ventricular and left ventricular leads.
Experimental: Current RF ICD Patients with ICD device will have the autocapture features of the device tested.	Device: Testing of the autocapture features of the device Patients with an Implantable Cardioverter Defibrillator will have new autocapture features tested on the right atrial and right ventricular leads.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746356

Locations

United States, Arkansas
Arkanasas Heart Hospital
Little Rock, Arkansas, United States, 72211
Baptist Health Hospital
Little Rock, Arkansas, United States, 73305
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
United States, Tennessee
St. Thomas Hospital
Nashville, Tennessee, United States, 37205
United States, Texas
Southwest Texas Methodist Hospital
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

St. Jude Medical

Investigators

Study Director:

Tamara Shipman

Director, Clinical Affairs, St. Jude Medical

More Information

No publications provided

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00746356 History of Changes
Other Study ID Numbers:	40005027, IDE # G080060, Doc number 40005027
Study First Received:	September 2, 2008
Results First Received:	July 24, 2011
Last Updated:	February 20, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Medical:

heart failure
cardiac resynchronization therapy
autocapture
Current RF
Promote RF

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013