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

Study Overview
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Brief Summary
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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
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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.

Official Title
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ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator Patients: A Prospective, Single-arm Safety Monitoring Study (ENHANCED-ICD Study)

Conditions
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Cardiac Arrhythmias

Intervention / Treatment
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* Device: Enhanced ICD programming


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced ICD programming<br> | Device: Enhanced ICD programming<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intervention-related safety events | Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ATPs/shocks | ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful. | 2 months post implantation | 
| Number of ATPs/shocks | ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful. | 6 months post implantation | 
| Number of ATPs/shocks | ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful. | 12 months post implantation | 
| Quality of life | EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12) | Baseline | 
| Quality of life | EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12) | 3 months post implantation | 
| Quality of life | EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12) | 6 months post implantation | 
| Quality of life | EuroQol 5D (EQ-5D) and Short Form Health Survey 12 (SF-12) | 12 months post implantation | 
| Distress | Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9) | Baseline | 
| Distress | Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9) | 3 months post implantation | 
| Distress | Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9) | 6 months post implantation | 
| Distress | Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9) | 12 months post implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrhythmias, Implantable Cardioverter-Defibrillator, Patient Safety, Quality of life