Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients

Cardiac Death Clinical Trial

— DECREASE  

Official title:

Reduction of Inappropriate ICD Therapies in Patients With Approved Indication for Primary Prevention of Sudden Cardiac Death

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217528
• Other study ID #: T76
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: January 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.

Description:

Inappropriate ICD therapies still remains a major issue with respect to patient's quality of life and proarrhythmic risk.

It's the aim of this study to determine efficacy of a dedicated programming concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Approved indication for new ICD implantation for primary prevention of sudden cardiac death

• Age >=18 Years

• Written informed consent

Exclusion Criteria:

• ICD indication for secondary prevention reasons

• ICD indication for "electrical" disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)

• ICD change or upgrade

• Pregnancy

• Nonage

• Patient is already participating to another study with active therapy arm

• Patient will most likely not be able to participate to the routine follow ups in the study center.

Related Conditions & MeSH terms

• Cardiac Death
• Death
• Death, Sudden, Cardiac

Intervention

Device:
• device settings for group A
VT zone: 350ms VF zone: 280ms
• Device settings for group B
VT zone: 320ms VF zone: 250ms

Locations

Country	Name	City	State
Germany	Medizinische Einrichtungen der RWTH Aachen	Aachen
Germany	Klinikum Altenburger Land GmbH	Altenburg
Germany	Städtisches Krankenhaus St. Barbara Attendorn GmbH	Attendorn
Germany	Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität	Bonn
Germany	Klinikum Coburg	Coburg
Germany	Klinik Fränkische Schweiz	Ebermannstadt
Germany	Kreiskrankenhaus Ebersberg	Ebersberg
Germany	Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang	Erfurt
Germany	Klinikum Esslingen	Esslingen
Germany	Universitätsklinik Freiburg	Freiburg
Germany	Krankenhaus Waltershausen-Friedrichroda	Friedrichroda
Germany	Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen	Gießen
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Oberhavel Kliniken GmbH Klinik Hennigsdorf	Henningsdorf
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Germany	Evangelisches Krankenhaus Kalk	Köln
Germany	Frankenwaldklinik Kronach GmbH	Kronach
Germany	Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen
Germany	St.-Marien-Hospital GmbH	Lünen
Germany	Klinikum Memmingen	Memmingen
Germany	Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber	München
Germany	Klinikum Großhadern der Ludwig-Maximilians-Universität München	München
Germany	Universitätsklinikum Münster	Münster
Germany	Klinikum Nürnberg	Nürnberg
Germany	Praxis Dres. med. Haggenmiller / Jeserich	Nürnberg
Germany	Kreiskrankenhaus des Bördekreises Krankenhaus 4	Oschersleben
Germany	Niels-Stensen-Kliniken Marienhospital Osnabrück	Osnabrück
Germany	Klinikum Pirna GmbH Klinik für Innere Medizin II	Pirna
Germany	Klinikum Dorothea Christiane Erxleben GmbH	Quedlinburg
Germany	Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes	Ratzeburg
Germany	Universität Rostock	Rostock
Germany	Katharinen-Hospital gGmbH	Unna
Germany	Helios Klinikum Wuppertal	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	Event free survival of: inappropriate ICD therapies (only stored tachycardias with proper stored EGM documentation are taken into account) AND; spontaneous, documented, sustained (>30s) ventricular tachycardia, that was not treated by the ICD	12 months
Secondary	Amount of patients with appropriate / inappropriate ICD therapies		12 months
Secondary	Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD		12 months
Secondary	Number and cycle lengths of supraventricular / ventricular tachys		12 months
Secondary	Time to first appropriate / inappropriate ICD therapy		12 months
Secondary	Sensitivity for diagnosis of sustained VT		12 months
Secondary	Specificity for SVT diagnosis		12 months
Secondary	Quality of Life (MLHF Questionaire)		12 months
Secondary	Overall mortality		12 months
Secondary	Cardiac mortality		12 months
Secondary	Frequency and efficacy of ATP prior to / before capacitor charging in VF zone		12 months
Secondary	Amount of patients with appropriate / inappropriate shocks or ATP		12 months