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

Not Applicable

Completed

• Conditions: Tachycardia
• Interventions: Device: ICD with enhanced SVT discriminators

• Registration Number: NCT01963286
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 735

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced SVT discriminators	ICD with enhanced SVT discriminators	Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ICD shocks for any reason	12 months	Freedom from automatically delivered ICD shocks for any reason during FU period
Inappropriate ICD therapies	12 months	Freedom from automatically delivered inappropriate ICD therapies during FU period
Untreated VT/VF	12 months	Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period
Cardiac deaths	12 months	Cardiac deaths
ICD/CRT-D related SAE	12 months	ICD/CRT-D related Serious Adverse Events (SAE)
Specificity	12 months	Specificity for...; * ... other than sustained VT/VF; * ... SVT (Supraventricular tachycardia); * ... different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT).
Sensitivity	12 months	Sensitivity for sustained VT/VF
Accuracy of ICD therapy decision	12 months	Accuracy of ICD therapy decision (VT/VF and nonVT/VF)

Trial Locations

Locations (23)

Tartu University Hospital; 🇪🇪 Tartu, Estonia

Klinikum Coburg GmbH; 🇩🇪 Coburg, Germany

Evangelisches Krankenhaus Kalk gGmbH; 🇩🇪 Köln, Germany

North Estonia Medical Centre; 🇪🇪 Tallinn, Estonia

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Universitäts-Herzzentrum Freiburg - Bad Krozingen; 🇩🇪 Freiburg, Germany

Praxis Dr. med. Stellmach; 🇩🇪 Chemnitz, Germany

Evangelisches Krankenhaus Holzminden gGmbH; 🇩🇪 Holzminden, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; 🇩🇪 Ludwigshafen, Germany

Klinikum Memmingen; 🇩🇪 Memmingen, Germany

Oberhavel Kliniken GmbH Klinik Hennigsdorf; 🇩🇪 Hennigsdorf, Germany

Medizinisches Versorgungszentrum am Küchwald GmbH; 🇩🇪 Chemnitz, Germany

Praxis Frau Dr. med. Gärtner; 🇩🇪 Leisnig, Germany

Gem.-Praxis Dres. med. Ebert / Stenzel; 🇩🇪 Riesa, Germany

Klinikum Esslingen; 🇩🇪 Esslingen, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Christliches Krankenhaus Quakenbrück gGmbH; 🇩🇪 Quakenbrück, Germany

Klinikum Oldenburg gGmbH; 🇩🇪 Oldenburg, Germany

Praxis Dr. med. Bernhardt; 🇩🇪 Annaberg-Buchholz, Germany

Caritas Krankenhaus; 🇩🇪 Bad Mergentheim, Germany

Hufeland Klinikum GmbH; 🇩🇪 Bad Langensalza, Germany

Hegau-Bodensee-Klinikum mbH; 🇩🇪 Singen, Germany