Clinical trial NCT01715116: ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator (ICD) Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrhythmias
Keywords: Cardiac arrhythmias
Implantable Cardioverter-Defibrillator
Patient Safety
Quality of life
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Tilburg University
name: Julius Center
First posted: 2012-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of intervention-related safety events
timeFrame: up to 12 months
Secondary outcomes:
measure: Number of ATPs/shocks
timeFrame: 2 months post implantation
measure: Number of ATPs/shocks
timeFrame: 6 months post implantation
measure: Number of ATPs/shocks
timeFrame: 12 months post implantation
measure: Quality of life
timeFrame: Baseline
measure: Quality of life
timeFrame: 3 months post implantation
measure: Quality of life
timeFrame: 6 months post implantation
measure: Quality of life
timeFrame: 12 months post implantation
measure: Distress
timeFrame: Baseline
measure: Distress
timeFrame: 3 months post implantation
measure: Distress
timeFrame: 6 months post implantation
measure: Distress
timeFrame: 12 months post implantation
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center
Study officials:
affiliation: University Medical Center
name: Mathias Meine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tilburg University
name: Susanne Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mastenbroek MH, Pedersen SS, van der Tweel I, Doevendans PA, Meine M. Results of ENHANCED Implantable Cardioverter Defibrillator Programming to Reduce Therapies and Improve Quality of Life (from the ENHANCED-ICD Study). Am J Cardiol. 2016 Feb 15;117(4):596-604. doi: 10.1016/j.amjcard.2015.11.052. Epub 2015 Dec 7.