Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
NCT ID: NCT01963286
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
735 participants
INTERVENTIONAL
2013-08-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enhanced SVT discriminators
Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings)
ICD with enhanced SVT discriminators
ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.
Interventions
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ICD with enhanced SVT discriminators
ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Johann C Geller, Prof. Dr.
Role: STUDY_CHAIR
Zentralklinik Bad Berka
Locations
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Praxis Dr. med. Bernhardt
Annaberg-Buchholz, , Germany
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Hufeland Klinikum GmbH
Bad Langensalza, , Germany
Caritas Krankenhaus
Bad Mergentheim, , Germany
North Estonia Medical Centre
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Medizinisches Versorgungszentrum am Küchwald GmbH
Chemnitz, , Germany
Praxis Dr. med. Stellmach
Chemnitz, , Germany
Klinikum Coburg GmbH
Coburg, , Germany
Evangelisches Krankenhaus Kalk gGmbH
Cologne, , Germany
Klinikum Esslingen
Esslingen am Neckar, , Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Oberhavel Kliniken GmbH Klinik Hennigsdorf
Hennigsdorf, , Germany
Evangelisches Krankenhaus Holzminden gGmbH
Holzminden, , Germany
Praxis Frau Dr. med. Gärtner
Leisnig, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, , Germany
Klinikum Memmingen
Memmingen, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinikum Oldenburg gGmbH
Oldenburg, , Germany
Christliches Krankenhaus Quakenbrück gGmbH
Quakenbrück, , Germany
Gem.-Praxis Dres. med. Ebert / Stenzel
Riesa, , Germany
Hegau-Bodensee-Klinikum mbH
Singen, , Germany
Countries
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Other Identifiers
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CR-12-092-GE-HV
Identifier Type: -
Identifier Source: org_study_id
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