NCT01715116

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M. Meine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cardiac Arrhythmias

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-10-26
• Last updated: 2013-04-17

Locations

1 site across 1 country: Netherlands