ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator (ICD) Patients

Not Applicable

• Conditions: Cardiac Arrhythmias

• Registration Number: NCT01715116
• Lead Sponsor: M. Meine

Brief Summary

The purpose of this study is to determine whether Enhanced device programming to reduce therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.

Detailed Description

ICD therapy has become the first-line treatment for the prevention of sudden cardiac death both as primary and secondary prevention due to its proven survival benefits as compared to anti-arrhythmic drugs. However, ICD therapy is associated with a number of complications and shocks that may impair patient quality of life and well being but also influence mortality. Hence, reduction of ICD shocks by means of alternative programming of the device is paramount for improving patient-centered outcomes and mortality.

The ENHANCED-ICD study will be a prospective, single-arm safety monitoring study. All patients will receive Enhanced programming. Furthermore, patients will be asked to complete a set of standardized and validated self-report questionnaires prior to ICD implantation, at 3-, 6-, and 12 months post implantation.

Study Timeline

• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-26
• Status Verified: 2013-04
• Study Start: 2013-04
• Last Update Submitted: 2013-04-16
• Last Update Posted: 2013-04-17
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• a primary or secondary prophylactic indication for ICD therapy according to the current European guidelines
• implanted with a Medtronic ProtectaTM ICD/CRT-D device or any future CE-approved and market-released Medtronic ICD/CRT-D devices with SmartShock technology
• between 18-80 years of age
• speaking and understanding Dutch
• providing written informed consent

Exclusion Criteria

• a life expectancy less than 1 year
• a history of psychiatric illness other than affective/anxiety disorders
• on the waiting list for heart transplantation
• insufficient knowledge of the Dutch language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of intervention-related safety events	up to 12 months	Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 months post implantation	EuroQol 5D (EQ-5D) and Short Form Health Survey 12 (SF-12)
Distress	12 months post implantation	Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)
Number of ATPs/shocks	12 months post implantation	ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.

Trial Locations

Locations (1)

University Medical Center; 🇳🇱 Utrecht, Netherlands