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

February 1, 2019 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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 receiving cardiac resynchronization therapy will have new autocapture features tested on right atrial, right ventricular and left ventricular leads.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Free of System-related Complications at 3-months Post Implant
Time Frame: 3 months post implant
3 months post implant
Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test
Time Frame: 3 months post implant
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
Time Frame: 3 months post implant
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
Time Frame: 3 months post implant
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
Time Frame: 3 months post implant
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tamara Shipman, Director, Clinical Affairs, St. Jude Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 40005027
  • IDE # G080060 (Other Identifier: FDA)
  • Doc number 40005027 (Other Identifier: St. Jude Medical)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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