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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrhythmias
• Intervention / Treatment: Device: Enhanced ICD programming

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathias Meine, MD, PhD; Phone Number: +31(0)884666184; Email: m.meine@umcutrecht.nl
• Study Contact Backup: Name: Susanne S Pedersen, PhD; Phone Number: + 31(0)134662067; Email: s.s.pedersen@uvt.nl

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3508 GA
    • Recruiting
    • University Medical Center
    • Principal Investigator: Mathias Meine, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Enhanced ICD programming

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: M. Meine
• Collaborators: Medtronic; Tilburg University; Julius Center
• Investigators: Principal Investigator: Mathias Meine, MD, PhD, University Medical Center; Principal Investigator: Susanne Pedersen, PhD, Tilburg University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 16, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Quality of life; Patient Safety; Implantable Cardioverter-Defibrillator; Cardiac arrhythmias
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 12/301