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

Tachycardia Clinical Trial

— ReduceIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963286
• Other study ID #: CR-12-092-GE-HV
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tachycardia

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