NCT01528657

Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.

Conditions

• Sick Sinus Syndrome

Interventions

Type	Name	Description
OTHER	Ventricular Pace Suppression (Vps)	Unnecessary ventricular pacing is avoided by promoting intrinsic conduction. In case of intrinsic conduction, the device switches from a DDD mode to an ADI mode.
OTHER	Intrinsic rhythm support (IRSplus)	All parameters of the AV hysteresis functions are set in a way to maintain spontaneous AV conduction of the patient's heart as long as possible.

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2012-02-08
• Last updated: 2015-10-22

Locations

20 sites across 1 country: Italy