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

Cardiac Arrhythmias Clinical Trial

— ENHANCED-ICD  

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)

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01715116
• Other study ID #: 12/301
• Status: Unknown status
• Phase: N/A
• First received: October 10, 2012
• Last updated: April 16, 2013
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2013
• Source: UMC Utrecht
• Contact: Mathias Meine, MD, PhD
• Phone: +31(0)884666184
• Email: m.meine[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
M. Meine	Julius Center, Medtronic, University of Tilburg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intervention-related safety events	Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.	up to 12 months
Secondary	Number of ATPs/shocks	ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.	2 months post implantation
Secondary	Number of ATPs/shocks	ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.	6 months post implantation
Secondary	Number of ATPs/shocks	ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.	12 months post implantation
Secondary	Quality of life	EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)	Baseline
Secondary	Quality of life	EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)	3 months post implantation
Secondary	Quality of life	EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)	6 months post implantation
Secondary	Quality of life	EuroQol 5D (EQ-5D) and Short Form Health Survey 12 (SF-12)	12 months post implantation
Secondary	Distress	Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9)	Baseline
Secondary	Distress	Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)	3 months post implantation
Secondary	Distress	Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)	6 months post implantation
Secondary	Distress	Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)	12 months post implantation