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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Cardiac Arrhythmias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enhanced ICD programming

Group Type EXPERIMENTAL

Enhanced ICD programming

Intervention Type DEVICE

* 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.

Interventions

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Enhanced 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No