Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators (ReduceIT)

January 31, 2019 updated by: Abbott Medical Devices
The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.

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

With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.

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.
735

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

  • Estonia
      • Tallinn, Estonia
        • North Estonia Medical Centre
      • Tartu, Estonia
        • Tartu University Hospital
  • Germany
      • Annaberg-Buchholz, Germany, 09456
        • Praxis Dr. med. Bernhardt
      • Bad Berka, Germany, 99438
        • Zentralklinik Bad Berka GmbH
      • Bad Langensalza, Germany, 99947
        • Hufeland Klinikum GmbH
      • Bad Mergentheim, Germany
        • Caritas Krankenhaus
      • Chemnitz, Germany, 09113
        • Medizinisches Versorgungszentrum am Küchwald GmbH
      • Chemnitz, Germany, 09126
        • Praxis Dr. Med. Stellmach
      • Coburg, Germany
        • Klinikum Coburg GmbH
      • Esslingen, Germany
        • Klinikum Esslingen
      • Freiburg, Germany
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Hennigsdorf, Germany
        • Oberhavel Kliniken GmbH Klinik Hennigsdorf
      • Holzminden, Germany, 37603
        • Evangelisches Krankenhaus Holzminden gGmbH
      • Köln, Germany
        • Evangelisches Krankenhaus Kalk gGmbH
      • Leisnig, Germany
        • Praxis Frau Dr. med. Gärtner
      • Ludwigshafen, Germany
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • Memmingen, Germany
        • Klinikum Memmingen
      • Münster, Germany
        • Universitatsklinikum Munster
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg gGmbH
      • Quakenbrück, Germany
        • Christliches Krankenhaus Quakenbrück gGmbH
      • Riesa, Germany
        • Gem.-Praxis Dres. med. Ebert / Stenzel
      • Singen, Germany
        • Hegau-Bodensee-Klinikum mbH

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:

  • Ischemic or nonischemic cardiomyopathy
  • Primary prevention or secondary prevention of Sudden cardiac death (SCD)
  • Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber)
  • The patient is ≥ 18 years of age
  • The patient is able to understand the patient information and is capable to provide informed consent.
  • The patient has provided written informed consent prior to any investigational related procedure

Exclusion Criteria:

  • Previously implanted ICD/CRT-D
  • Hypertrophic (with or without obstructive) cardiomyopathy
  • Ion channel disorders (Long/Short-QT, Brugada syndrome etc…)
  • New York Heart Association (NYHA) Class IV
  • Recent cardiac decompensation (within previous 3 months)
  • The patient is unable to comply with the follow up schedule.
  • The patient is participating in another investigational device or drug investigation.
  • The patient is pregnant or is planning to become pregnant during the duration of the investigation

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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.
OTHER: Enhanced SVT discriminators
Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings)
Device: ICD with enhanced SVT discriminators
ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.
Other Names:
  • Ellipse (St. Jude Medical)
  • Fortify Assura (St. Jude Medical)
  • Unify Assura (St. Jude Medical)

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
Inappropriate ICD shocks
Time Frame: 12 months
Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ICD shocks for any reason
Time Frame: 12 months
Freedom from automatically delivered ICD shocks for any reason during FU period
12 months
Inappropriate ICD therapies
Time Frame: 12 months
Freedom from automatically delivered inappropriate ICD therapies during FU period
12 months
Untreated VT/VF
Time Frame: 12 months
Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period
12 months
Accuracy of ICD therapy decision
Time Frame: 12 months
Accuracy of ICD therapy decision (VT/VF and nonVT/VF)
12 months
Specificity
Time Frame: 12 months

Specificity for…

  • … other than sustained VT/VF
  • … SVT (Supraventricular tachycardia)
  • … different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT).
12 months
Cardiac deaths
Time Frame: 12 months
Cardiac deaths
12 months
Sensitivity
Time Frame: 12 months
Sensitivity for sustained VT/VF
12 months
ICD/CRT-D related SAE
Time Frame: 12 months
ICD/CRT-D related Serious Adverse Events (SAE)
12 months

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 Chair: Johann C Geller, Prof. Dr., Zentralklinik Bad Berka

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, 2013

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.
October 1, 2016

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.
October 1, 2016

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 12, 2013

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.
October 11, 2013

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.
October 16, 2013

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 4, 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.
January 31, 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.
January 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.
  • CR-12-092-GE-HV

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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