NCT00562107

Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients. The expected benefits will be a result of the reduction of the percentage of ventricular pacing. It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation. The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)

Conditions

• Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.

Interventions

Type	Name	Description
DEVICE	Symphony DR 2550 and REPLY DR cardiac pacemakers	AAISafeR/SafeR ON
DEVICE	Symphony DR 2550 and REPLY DR cardiac pacemakers	DDD(R) (SafeR OFF)

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-03-01
• Completion: 2013-04-01
• First posted: 2007-11-21
• Last updated: 2014-09-29

Locations

37 sites across 6 countries: United States, France, Germany, Italy, Spain, United Kingdom