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

NCT ID: NCT00746356

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-01-31

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.

Conditions

Heart Failure; Ventricular Arrythmias

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Promote RF CRT-D

Patients with CRT-D device will have the autocapture features of the device tested.

Group Type: EXPERIMENTAL

Testing of the autocapture features of the device

Intervention Type: DEVICE

Patients receiving cardiac resynchronization therapy will have new autocapture features tested on right atrial, right ventricular and left ventricular leads.

Current RF ICD

Patients with ICD device will have the autocapture features of the device tested.

Group Type: EXPERIMENTAL

Testing of the autocapture features of the device

Intervention Type: DEVICE

Patients with an Implantable Cardioverter Defibrillator will have new autocapture features tested on the right atrial and right ventricular leads.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamara Shipman

Role: STUDY_DIRECTOR

Director, Clinical Affairs, St. Jude Medical

Locations

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

Countries

United States

Other Identifiers

IDE # G080060

Identifier Type: OTHER

Identifier Source: secondary_id

Doc number 40005027

Identifier Type: OTHER

Identifier Source: secondary_id

40005027

Identifier Type: -

Identifier Source: org_study_id