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

M. Meine

Status: Unknown

Conditions: Cardiac Arrhythmias

Treatments: Device: Enhanced ICD programming

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01715116

12/301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Enhanced ICD programming

Experimental group

Treatment:

Device: Enhanced ICD programming