Clinical trial NCT01963286: Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
Official title: Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia
Keywords: ICD
CRT-D
Sudden cardiac death
Device settings
Optimized programming strategy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-10-16
Enrollment: 735
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inappropriate ICD shocks
timeFrame: 12 months
Secondary outcomes:
measure: ICD shocks for any reason
timeFrame: 12 months
measure: Inappropriate ICD therapies
timeFrame: 12 months
measure: Untreated VT/VF
timeFrame: 12 months
measure: Accuracy of ICD therapy decision
timeFrame: 12 months
measure: Specificity
timeFrame: 12 months
measure: Cardiac deaths
timeFrame: 12 months
measure: Sensitivity
timeFrame: 12 months
measure: ICD/CRT-D related SAE
timeFrame: 12 months
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Annaberg-Buchholz
country: Germany
facility: Praxis Dr. med. Bernhardt
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Langensalza
country: Germany
facility: Hufeland Klinikum GmbH
city: Bad Mergentheim
country: Germany
facility: Caritas Krankenhaus
city: Chemnitz
country: Germany
facility: Medizinisches Versorgungszentrum am Küchwald GmbH
city: Chemnitz
country: Germany
facility: Praxis Dr. med. Stellmach
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken GmbH Klinik Hennigsdorf
city: Holzminden
country: Germany
facility: Evangelisches Krankenhaus Holzminden gGmbH
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk gGmbH
city: Leisnig
country: Germany
facility: Praxis Frau Dr. med. Gärtner
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Memmingen
country: Germany
facility: Klinikum Memmingen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg gGmbH
city: Quakenbrück
country: Germany
facility: Christliches Krankenhaus Quakenbrück gGmbH
city: Riesa
country: Germany
facility: Gem.-Praxis Dres. med. Ebert / Stenzel
city: Singen
country: Germany
facility: Hegau-Bodensee-Klinikum mbH
Study officials:
affiliation: Zentralklinik Bad Berka
name: Johann C Geller, Prof. Dr.
role: STUDY_CHAIR
References: