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

NCT01963286 | Completed DMC

• 1 other identifier: CR-12-092-GE-HV
• Study Type: interventional
• Target: 735
• Locations: 2 countries
• Sites: 23

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.

Conditions

Tachycardia

Keywords

ICD; CRT-D; Sudden cardiac death; Device settings; Optimized programming strategy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• ICD shocks for any reason

  12 months

• Inappropriate ICD therapies

  12 months

• Untreated VT/VF

  12 months

• Accuracy of ICD therapy decision

  12 months

• Specificity

  12 months

Study Arms (1)

Enhanced SVT discriminators

OTHER

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

Device: ICD with enhanced SVT discriminators

Interventions

ICD with enhanced SVT discriminators DEVICE

ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.

Also known as: Ellipse (St. Jude Medical), Fortify Assura (St. Jude Medical), Unify Assura (St. Jude Medical)

Enhanced SVT discriminators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (23)

North Estonia Medical Centre

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

Praxis Dr. med. Bernhardt

Annaberg-Buchholz, 09456, Germany

Location

Zentralklinik Bad Berka GmbH

Bad Berka, 99438, Germany

Location

Hufeland Klinikum GmbH

Bad Langensalza, 99947, Germany

Location

Caritas Krankenhaus

Bad Mergentheim, Germany

Location

Medizinisches Versorgungszentrum am Küchwald GmbH

Chemnitz, 09113, Germany

Location

Praxis Dr. med. Stellmach

Chemnitz, 09126, Germany

Location

Klinikum Coburg GmbH

Coburg, Germany

Location

Evangelisches Krankenhaus Kalk gGmbH

Cologne, Germany

Location

Klinikum Esslingen

Esslingen am Neckar, Germany

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Freiburg im Breisgau, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Oberhavel Kliniken GmbH Klinik Hennigsdorf

Hennigsdorf, Germany

Location

Evangelisches Krankenhaus Holzminden gGmbH

Holzminden, 37603, Germany

Location

Praxis Frau Dr. med. Gärtner

Leisnig, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany

Location

Klinikum Memmingen

Memmingen, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Klinikum Oldenburg gGmbH

Oldenburg, 26133, Germany

Location

Christliches Krankenhaus Quakenbrück gGmbH

Quakenbrück, Germany

Location

Gem.-Praxis Dres. med. Ebert / Stenzel

Riesa, Germany

Location

Hegau-Bodensee-Klinikum mbH

Singen, Germany

Location

MeSH Terms

Conditions

Tachycardia; Death, Sudden, Cardiac

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Johann C Geller, Prof. Dr.

  Zentralklinik Bad Berka

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: October 16, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

ES (2); DE (21)