MedTrace Logo

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

NCT01715116 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-04-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Tilburg University

    collaborator OTHER

  • Julius Center

    collaborator OTHER

  • M. Meine

    lead OTHER

Principal Investigators

  • Mathias Meine, MD, PhD · University Medical Center

  • Susanne Pedersen, PhD · Tilburg University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01715116 on ClinicalTrials.gov