ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator (ICD) Patients
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
University Medical Center🇳🇱Utrecht, NetherlandsMathias Meine, MD, PhDPrincipal Investigator