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

Primary Purpose

Heart Failure, Ventricular Arrythmias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testing of the autocapture features of the device
Testing of the autocapture features of the device
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, cardiac resynchronization therapy, autocapture, Current RF, Promote RF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arkanasas Heart Hospital
  • Baptist Health Hospital
  • Deborah Heart and Lung Center
  • St. Thomas Hospital
  • Southwest Texas Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Promote RF CRT-D

Current RF ICD

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants Free of System-related Complications at 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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2008
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00746356
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Arrythmias
Keywords
heart failure, cardiac resynchronization therapy, autocapture, Current RF, Promote RF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Promote RF CRT-D
Arm Type
Experimental
Arm Description
Patients with CRT-D device will have the autocapture features of the device tested.
Arm Title
Current RF ICD
Arm Type
Experimental
Arm Description
Patients with ICD device will have the autocapture features of the device tested.
Intervention Type
Device
Intervention Name(s)
Testing of the autocapture features of the device
Intervention Description
Patients receiving cardiac resynchronization therapy will have new autocapture features tested on right atrial, right ventricular and left ventricular leads.
Intervention Type
Device
Intervention Name(s)
Testing of the autocapture features of the device
Intervention Description
Patients with an Implantable Cardioverter Defibrillator will have new autocapture features tested on the right atrial and right ventricular leads.
Primary Outcome Measure Information:
Title
Percentage of Participants Free of System-related Complications at 3-months Post Implant
Time Frame
3 months post implant
Title
Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test
Description
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.
Time Frame
3 months post implant
Title
Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test
Description
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.
Time Frame
3 months post implant
Title
Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test
Description
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.
Time Frame
3 months post implant
Title
Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test
Description
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.
Time Frame
3 months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Shipman
Organizational Affiliation
Director, Clinical Affairs, St. Jude Medical
Official's Role
Study Director
Facility Information:
Facility Name
Arkanasas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Baptist Health Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
73305
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Southwest Texas Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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