Cardiac Arrhythmias
Conditions
Keywords
Cardiac arrhythmias, Implantable Cardioverter-Defibrillator, Patient Safety, Quality of life
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.
Interventions
DEVICEEnhanced ICD programming
* VT monitor: \> 166/min * fVT: \> 182/min; via VF 60/80 intervals (number of intervals to start ATP after approximately 20 s); 3 x ATP (8 stimuli, 88%, scan 20 ms); shock 1-5: 35 J; redetection 30/40 intervals. * VF: \> 250/min; via VF 60/80 intervals (number of intervals to start therapy after approximately 15 s); 1 x ATP (8 stimuli, 88%) during charging; all shocks: 35 J; redetection 30/40 intervals * SVT/VT discrimination is turned on, high rate time out is OFF * SVT/VT discrimination single chamber: stability, wavelet; SVT upper rate limit: 222/min * SVT/VT discrimination dual/triple chamber: P/R logic, wavelet; SVT upper rate limit: 222/min * T wave-oversensing and lead noise discrimination is turned on in all devices.
Sponsors
Medtronic
Tilburg University
Julius Center
M. Meine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of intervention-related safety events | up to 12 months | Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ATPs/shocks | 2 months post implantation | ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful. |
| Quality of life | Baseline | EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12) |
| Distress | Baseline | Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9) |
Countries
Netherlands
Contacts
Primary ContactMathias Meine, MD, PhD
Backup ContactSusanne S Pedersen, PhD
Outcome results
None listed