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

Primary Purpose

Tachycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ICD with enhanced SVT discriminators
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia focused on measuring ICD, CRT-D, Sudden cardiac death, Device settings, Optimized programming strategy

Eligibility Criteria

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

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

Sites / Locations

  • North Estonia Medical Centre
  • Tartu University Hospital
  • Praxis Dr. med. Bernhardt
  • Zentralklinik Bad Berka GmbH
  • Hufeland Klinikum GmbH
  • Caritas Krankenhaus
  • Medizinisches Versorgungszentrum am Küchwald GmbH
  • Praxis Dr. med. Stellmach
  • Klinikum Coburg GmbH
  • Klinikum Esslingen
  • Universitäts-Herzzentrum Freiburg - Bad Krozingen
  • Medizinische Hochschule Hannover
  • Oberhavel Kliniken GmbH Klinik Hennigsdorf
  • Evangelisches Krankenhaus Holzminden gGmbH
  • Evangelisches Krankenhaus Kalk gGmbH
  • Praxis Frau Dr. med. Gärtner
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Klinikum Memmingen
  • Universitätsklinikum Münster
  • Klinikum Oldenburg gGmbH
  • Christliches Krankenhaus Quakenbrück gGmbH
  • Gem.-Praxis Dres. med. Ebert / Stenzel
  • Hegau-Bodensee-Klinikum mbH

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Enhanced SVT discriminators

Arm Description

Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ICD shocks for any reason
Freedom from automatically delivered ICD shocks for any reason during FU period
Inappropriate ICD therapies
Freedom from automatically delivered inappropriate ICD therapies during FU period
Untreated VT/VF
Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period
Accuracy of ICD therapy decision
Accuracy of ICD therapy decision (VT/VF and nonVT/VF)
Specificity
Specificity for… … other than sustained VT/VF … SVT (Supraventricular tachycardia) … different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT).
Cardiac deaths
Cardiac deaths
Sensitivity
Sensitivity for sustained VT/VF
ICD/CRT-D related SAE
ICD/CRT-D related Serious Adverse Events (SAE)

Full Information

First Posted
September 12, 2013
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01963286
Brief Title
Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
Acronym
ReduceIT
Official Title
Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia
Keywords
ICD, CRT-D, Sudden cardiac death, Device settings, Optimized programming strategy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
735 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced SVT discriminators
Arm Type
Other
Arm Description
Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings)
Intervention Type
Device
Intervention Name(s)
ICD with enhanced SVT discriminators
Other Intervention Name(s)
Ellipse (St. Jude Medical), Fortify Assura (St. Jude Medical), Unify Assura (St. Jude Medical)
Intervention Description
ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.
Primary Outcome Measure Information:
Title
Inappropriate ICD shocks
Description
Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ICD shocks for any reason
Description
Freedom from automatically delivered ICD shocks for any reason during FU period
Time Frame
12 months
Title
Inappropriate ICD therapies
Description
Freedom from automatically delivered inappropriate ICD therapies during FU period
Time Frame
12 months
Title
Untreated VT/VF
Description
Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period
Time Frame
12 months
Title
Accuracy of ICD therapy decision
Description
Accuracy of ICD therapy decision (VT/VF and nonVT/VF)
Time Frame
12 months
Title
Specificity
Description
Specificity for… … other than sustained VT/VF … SVT (Supraventricular tachycardia) … different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT).
Time Frame
12 months
Title
Cardiac deaths
Description
Cardiac deaths
Time Frame
12 months
Title
Sensitivity
Description
Sensitivity for sustained VT/VF
Time Frame
12 months
Title
ICD/CRT-D related SAE
Description
ICD/CRT-D related Serious Adverse Events (SAE)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann C Geller, Prof. Dr.
Organizational Affiliation
Zentralklinik Bad Berka
Official's Role
Study Chair
Facility Information:
Facility Name
North Estonia Medical Centre
City
Tallinn
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Facility Name
Praxis Dr. med. Bernhardt
City
Annaberg-Buchholz
ZIP/Postal Code
09456
Country
Germany
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
ZIP/Postal Code
99438
Country
Germany
Facility Name
Hufeland Klinikum GmbH
City
Bad Langensalza
ZIP/Postal Code
99947
Country
Germany
Facility Name
Caritas Krankenhaus
City
Bad Mergentheim
Country
Germany
Facility Name
Medizinisches Versorgungszentrum am Küchwald GmbH
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Praxis Dr. med. Stellmach
City
Chemnitz
ZIP/Postal Code
09126
Country
Germany
Facility Name
Klinikum Coburg GmbH
City
Coburg
Country
Germany
Facility Name
Klinikum Esslingen
City
Esslingen
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg - Bad Krozingen
City
Freiburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Oberhavel Kliniken GmbH Klinik Hennigsdorf
City
Hennigsdorf
Country
Germany
Facility Name
Evangelisches Krankenhaus Holzminden gGmbH
City
Holzminden
ZIP/Postal Code
37603
Country
Germany
Facility Name
Evangelisches Krankenhaus Kalk gGmbH
City
Köln
Country
Germany
Facility Name
Praxis Frau Dr. med. Gärtner
City
Leisnig
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen
Country
Germany
Facility Name
Klinikum Memmingen
City
Memmingen
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
Klinikum Oldenburg gGmbH
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Christliches Krankenhaus Quakenbrück gGmbH
City
Quakenbrück
Country
Germany
Facility Name
Gem.-Praxis Dres. med. Ebert / Stenzel
City
Riesa
Country
Germany
Facility Name
Hegau-Bodensee-Klinikum mbH
City
Singen
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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