NCT01715116

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

3 years

First QC Date

October 10, 2012

Last Update Submit

April 16, 2013

Conditions

Cardiac Arrhythmias

Keywords

Cardiac arrhythmiasImplantable Cardioverter-DefibrillatorPatient SafetyQuality of life

Outcome Measures

Primary Outcomes (1)

  • Number of intervention-related safety events

    Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.

    up to 12 months

Secondary Outcomes (11)

  • Number of ATPs/shocks

    2 months post implantation

  • Number of ATPs/shocks

    6 months post implantation

  • Number of ATPs/shocks

    12 months post implantation

  • Quality of life

    Baseline

  • Quality of life

    3 months post implantation

  • +6 more secondary outcomes

Study Arms (1)

Enhanced ICD programming

EXPERIMENTAL
Device: Enhanced ICD programming

Interventions

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.

Enhanced ICD programming

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Utrecht, 3508 GA, Netherlands

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40820765DERIVED

  • 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.

    PMID: 26732419DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mathias Meine, MD, PhD

    University Medical Center

    PRINCIPAL INVESTIGATOR

  • Susanne Pedersen, PhD

    Tilburg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathias Meine, MD, PhD

CONTACT

+31(0)884666184m.meine@umcutrecht.nl

Susanne S Pedersen, PhD

CONTACT

+ 31(0)134662067s.s.pedersen@uvt.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mathias Meine, MD, PhD

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 26, 2012

Study Start

April 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

NL(1)