Cardiac ArrhythmiasENHANCED-ICDNCT01715116
ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator (ICD) Patients
A study testing Enhanced ICD programming in people with Cardiac Arrhythmias, run by M. Meine at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- Enhanced ICD programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center
Utrecht, 3508 GA
Mathias Meine, MD, PhD
About this study
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)
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.
Read the 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.
- Conditions
- Cardiac Arrhythmias
- Being tested
- Enhanced ICD programming
- Keywords
- Cardiac arrhythmias, Implantable Cardioverter-Defibrillator, Patient Safety, Quality of life
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced ICD programmingDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced ICD programming | Experimental | Not described Receives: Device: Enhanced ICD programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intervention-related safety events
Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.
Measured: up to 12 months
Secondary outcomes (11)
Number of ATPs/shocks
ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.
Measured: 2 months post implantation
Number of ATPs/shocks
ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.
Measured: 6 months post implantation
Number of ATPs/shocks
ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.
Measured: 12 months post implantation
Quality of life
EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)
Measured: Baseline
Quality of life
EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)
Measured: 3 months post implantation
Quality of life
EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)
Measured: 6 months post implantation
Quality of life
EuroQol 5D (EQ-5D) and Short Form Health Survey 12 (SF-12)
Measured: 12 months post implantation
Distress
Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9)
Measured: Baseline
Distress
Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)
Measured: 3 months post implantation
Distress
Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)
Measured: 6 months post implantation
Distress
Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)
Measured: 12 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M. Meine
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Tilburg University, Julius Center
- Responsible party
- Sponsor-investigator, M. Meine, UMC Utrecht
- Investigators
- Mathias Meine, MD, PhD, Principal investigator, University Medical CenterSusanne Pedersen, PhD, Principal investigator, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715116
- Sponsor's protocol ID
- 12/301
- Acronym
- ENHANCED-ICD
- Status last verified
- Apr 2013
- First submitted
- 10 Oct 2012
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chiu CSL, van Dijkhuizen A, Gerrits W, Cramer MJ, Tuinenburg AE, van der Harst P, Meine M. Reducing Unnecessary Implantable Cardioverter-Defibrillator Therapy With ENHANCED Programming: Long-Term Outcomes of the ENHANCED-ICD Study. J Cardiovasc Electrophysiol. 2025 Nov;36(11):2861-2869. doi: 10.1111/jce.70060. Epub 2025 Aug 18.
PubMed 40820765Mastenbroek 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.
PubMed 26732419
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01715116
- Acronym / sponsor ID
- ENHANCED-ICD / 12/301
- Conditions
- Cardiac Arrhythmias
- Keywords
- Cardiac arrhythmias, Implantable Cardioverter-Defibrillator, Patient Safety, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M. MeineUniversity, hospital or other
- Collaborators
- Medtronic, Tilburg University, Julius Center
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced ICD programming | Experimental | Device: Enhanced ICD programming |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Enhanced ICD programming |
Primary outcome
Number of intervention-related safety events
Time frame: up to 12 months
Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.
11 secondary outcomes
Number of ATPs/shocks
Time frame: 2 months post implantation
Number of ATPs/shocks
Time frame: 6 months post implantation
Number of ATPs/shocks
Time frame: 12 months post implantation
Quality of life
Time frame: Baseline
Quality of life
Time frame: 3 months post implantation
Quality of life
Time frame: 6 months post implantation
Quality of life
Time frame: 12 months post implantation
Distress
Time frame: Baseline
Distress
Time frame: 3 months post implantation
Distress
Time frame: 6 months post implantation
Distress
Time frame: 12 months post implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Derived from this study: PubMed 40820765Chiu CSL, van Dijkhuizen A, Gerrits W, Cramer MJ, Tuinenburg AE, van der Harst P, Meine M. Reducing Unnecessary Implantable Cardioverter-Defibrillator Therapy With ENHANCED Programming: Long-Term Outcomes of the ENHANCED-ICD Study. J Cardiovasc Electrophysiol. 2025 Nov;36(11):2861-2869. doi: 10.1111/jce.70060. Epub 2025 Aug 18.
- Derived from this study: PubMed 26732419Mastenbroek 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.
Related trials for Cardiac Arrhythmias
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingPhase 4
A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Meine, MD, PhD principal investigator
University Medical Center
Susanne Pedersen, PhD principal investigator
Tilburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced ICD programming in people with Cardiac Arrhythmias, run by M. Meine at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathias Meine, MD, PhD (+31(0)884666184, m.meine@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intervention-related safety events (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715116, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.