MedTrace Logo

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

NCT00562107 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2014-09-29

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Stockburger Martin, MD · Head of Pacemaker/Defibrillator/CRT department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-03-31
Completion
2013-04-30

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00562107 on ClinicalTrials.gov