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

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: Completed
• Conditions: Tachycardia
• Intervention / Treatment: Device: ICD with enhanced SVT discriminators

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: Interventional
• Enrollment (Actual): 735
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICD shocks for any reason	Freedom from automatically delivered ICD shocks for any reason during FU period	12 months
Inappropriate ICD therapies	Freedom from automatically delivered inappropriate ICD therapies during FU period	12 months
Untreated VT/VF	Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period	12 months
Accuracy of ICD therapy decision	Accuracy of ICD therapy decision (VT/VF and nonVT/VF)	12 months
Specificity	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	Cardiac deaths	12 months
Sensitivity	Sensitivity for sustained VT/VF	12 months
ICD/CRT-D related SAE	ICD/CRT-D related Serious Adverse Events (SAE)	12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Johann C Geller, Prof. Dr., Zentralklinik Bad Berka

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (ESTIMATE): October 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: ICD; Sudden cardiac death; CRT-D; Device settings; Optimized programming strategy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: CR-12-092-GE-HV