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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01963286
Other study ID # CR-12-092-GE-HV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2013
Est. completion date October 2016

Study information

Verified date January 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 735
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Estonia North Estonia Medical Centre Tallinn
Estonia Tartu University Hospital Tartu
Germany 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 Medizinisches Versorgungszentrum am Küchwald GmbH Chemnitz
Germany Praxis Dr. med. Stellmach Chemnitz
Germany Klinikum Coburg GmbH Coburg
Germany Klinikum Esslingen Esslingen
Germany Universitäts-Herzzentrum Freiburg - Bad Krozingen Freiburg
Germany Medizinische Hochschule Hannover Hannover
Germany Oberhavel Kliniken GmbH Klinik Hennigsdorf Hennigsdorf
Germany Evangelisches Krankenhaus Holzminden gGmbH Holzminden
Germany Evangelisches Krankenhaus Kalk gGmbH Köln
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

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Estonia,  Germany, 

Outcome

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