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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Tilburg University | OTHER |
| Julius Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced ICD programming | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced ICD programming | Device |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathias Meine, MD, PhD | Contact | +31(0)884666184 | m.meine@umcutrecht.nl | |
| Susanne S Pedersen, PhD | Contact | + 31(0)134662067 | s.s.pedersen@uvt.nl |
| Name | Affiliation | Role |
|---|---|---|
| Mathias Meine, MD, PhD | University Medical Center | Principal Investigator |
| Susanne Pedersen, PhD | Tilburg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Recruiting | Utrecht | 3508 GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40820765 | Derived | 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. | |
| 26732419 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 6, 2017 | |
| Unrelease | Jun 6, 2018 | |
| Release | Jun 6, 2018 | |
| Reset | Dec 20, 2018 | |
| Release | Sep 30, 2021 | |
| Reset | Oct 28, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 6, 2017 | Jun 6, 2018 | |||
| Jun 6, 2018 |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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 |
| 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. |
| Dec 20, 2018 |
| Sep 30, 2021 | Oct 28, 2021 |