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

NCT00746356 | Completed Results

• 3 other identifiers: 40005027IDE # G080060Doc number 40005027
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure; Ventricular Arrythmias

Keywords

heart failure; cardiac resynchronization therapy; autocapture; Current RF; Promote RF

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants Free of System-related Complications at 3-months Post Implant

  3 months post implant

• Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test

  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.

  3 months post implant

• Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test

  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.

  3 months post implant

• Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test

  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.

  3 months post implant

• Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test

  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.

  3 months post implant

Study Arms (2)

Promote RF CRT-D

EXPERIMENTAL

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

Device: Testing of the autocapture features of the device

Current RF ICD

EXPERIMENTAL

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

Device: Testing of the autocapture features of the device

Interventions

Testing of the autocapture features of the device DEVICE

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

Promote RF CRT-D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

Arkanasas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Baptist Health Hospital

Little Rock, Arkansas, 73305, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Southwest Texas Methodist Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ashish Oza, Clinical Studies Director
• Organization: St. Jude Medical

aoza@sjm.com

818 362 6822

Study Officials

• Tamara Shipman

  Director, Clinical Affairs, St. Jude Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: January 1, 2010
• Last Updated: February 19, 2019
• Results First Posted: March 1, 2013

Record last verified: 2019-02

Locations

US (5)