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)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of intervention-related safety events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Enhanced ICD programming
Intervention: Enhanced ICD programming (Device)
Outcomes
Primary Outcomes
Number of intervention-related safety events
Time Frame: up to 12 months
Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.
Secondary Outcomes
- Quality of life(12 months post implantation)
- Distress(12 months post implantation)
- Number of ATPs/shocks(12 months post implantation)
- Number of ATPs/shocks(2 months post implantation)
- Number of ATPs/shocks(6 months post implantation)
- Quality of life(Baseline)
- Quality of life(3 months post implantation)
- Quality of life(6 months post implantation)
- Distress(Baseline)
- Distress(3 months post implantation)
- Distress(6 months post implantation)
Investigators
M. Meine
Mathias Meine, MD, PhD
UMC Utrecht