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

This study is currently recruiting participants.
Verified April 2013 by UMC Utrecht
Sponsor:
Collaborators:
Medtronic
University of Tilburg
Julius Center
Information provided by (Responsible Party):
M. Meine, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01715116
First received: October 10, 2012
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Arrhythmias
 Device: Enhanced ICD programming

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Number of intervention-related safety events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.


Secondary Outcome Measures:
  • Number of ATPs/shocks [ Time Frame: 2 months post implantation ] [ Designated as safety issue: Yes ]
    ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.

  • Number of ATPs/shocks [ Time Frame: 6 months post implantation ] [ Designated as safety issue: Yes ]
    ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.

  • Number of ATPs/shocks [ Time Frame: 12 months post implantation ] [ Designated as safety issue: Yes ]
    ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.

  • Quality of life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)

  • Quality of life [ Time Frame: 3 months post implantation ] [ Designated as safety issue: No ]
    EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)

  • Quality of life [ Time Frame: 6 months post implantation ] [ Designated as safety issue: No ]
    EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)

  • Quality of life [ Time Frame: 12 months post implantation ] [ Designated as safety issue: No ]
    EuroQol 5D (EQ-5D) and Short Form Health Survey 12 (SF-12)

  • Distress [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9)

  • Distress [ Time Frame: 3 months post implantation ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)

  • Distress [ Time Frame: 6 months post implantation ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)

  • Distress [ Time Frame: 12 months post implantation ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715116

Contacts
Contact: Mathias Meine, MD, PhD +31(0)884666184 m.meine@umcutrecht.nl
Contact: Susanne S Pedersen, PhD + 31(0)134662067 s.s.pedersen@uvt.nl

Locations
Netherlands
University Medical Center Recruiting
Utrecht, Netherlands, 3508 GA
Principal Investigator: Mathias Meine, MD, PhD            
Sponsors and Collaborators
M. Meine
Medtronic
University of Tilburg
Julius Center
Investigators
Principal Investigator: Mathias Meine, MD, PhD University Medical Center
Principal Investigator: Susanne Pedersen, PhD University of Tilburg
  More Information

No publications provided

Responsible Party: M. Meine, Mathias Meine, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01715116     History of Changes
Other Study ID Numbers: 12/301
Study First Received: October 10, 2012
Last Updated: April 16, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Cardiac arrhythmias
Implantable Cardioverter-Defibrillator
Patient Safety
Quality of life

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013