Rationale and design for programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock (PROVIDE) study.

AIMS

Shock therapy delivery by implantable cardioverter-defibrillators (ICD) can be painful and may have negative psychological consequences. Reducing shock burden for patients with ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) may have beneficial consequences. This may be achieved by avoiding inappropriate shocks for supraventricular tachycardia (SVT) and by limiting appropriate shocks to only those that are necessary to convert ventricular arrhythmias.

METHODS AND RESULTS

The programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock study (PROVIDE) is a prospective, randomized, multicentre study that will test the hypothesis that a combination of pre-selected ventricular tachyarrhythmia detection, anti-tachycardia pacing, and SVT discriminator parameters will prolong the time to first shock without increasing arrhythmic syncope in patients receiving ICDs for primary prevention. Patients receiving St Jude Medical ICDs and CRT-Ds for primary prevention will be randomized 1:1 to one of two arrhythmia detection and therapy approaches. The study will enroll and follow 1600 patients for at least 1 year or until 226 first shocks have been documented in the total study population. The primary endpoint of the study is the mean time to first shock and the safety endpoint is the rate of arrhythmic syncope.

CONCLUSION

The PROVIDE trial is a randomized controlled study, designed to assess if a pre-selected combination of programming parameters can reduce shock burden among patients receiving ICDs/CRT-Ds for primary prevention.