Clinical trial NCT00562107: Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
Official title: Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
Keywords: Minimized ventricular pacing, clinical outcome, SafeR, AAIsafeR, dual chamber pacemaker therapy, % of ventricular pacing, hospitalizations, symptomatic AF
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 650
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: Inclusion Criteria:

* Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines.
* Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block.
* Patient implanted with a bipolar right atrial lead and a right ventricular lead
* Patient has signed a consent form after having received the appropriate information

Exclusion Criteria:

* Patient with permanent AF
* Patient suffering from sustained ventricular arrhythmias
* Patient with congenital complete heart block
* Patient with vasovagal syncope, carotid sinus syndrome
* Patient with AV node ablation
* Patient having suffered from a myocardial infarction within the last month
* Patient suffering from severe aortic stenosis
* Patient suffering from unstable angina pectoris
* Patient is not able to understand the study objectives and protocol or refuses to co-operate
* Patient is not available for scheduled follow-up
* Patient has a life expectancy less than one year
* Patient is included into another clinical study
* Patient is minor, this is \< 18 years
* Patient is a pregnant woman
* Any patient with a contra-indication for the device labeling

Primary outcomes:
measure: The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)
timeFrame: 3 years
Secondary outcomes:
measure: Evolution of paroxysmal AV blocks
timeFrame: 3 years
Other outcomes:
Locations:
city: Brighton
country: United States
facility: 736 Cambridge Street
state: Massachusetts
city: Amiens
country: France
facility: CHU - Hopital Sud
city: Béthune
country: France
facility: Centre hospitalier de Béthune
city: Grenoble
country: France
facility: CHU - Hopital Michallon
city: Marseille
country: France
facility: CHP Beauregard
city: Montpellier
country: France
facility: CHU A de Villeneuve
city: Paris cedex 16
country: France
facility: Clinique Bizet
city: Rouen
country: France
facility: CHU Hopital C. Nicolle
city: Saint Denis
country: France
facility: CCN
city: Saint Etienne
country: France
facility: CHU - Hopital Nord
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHU Hopital Trousseau
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy
city: Berlin
country: Germany
facility: Charite Virchow
city: Bernau
country: Germany
facility: Bernau hospital
city: Braunschweig
country: Germany
facility: Braunschweig hospital
city: Essen
country: Germany
facility: Elisabeth KH Essen
city: Leipzig
country: Germany
facility: Leipzig Uni
city: Lübeck
country: Germany
facility: Lübeck Uni
city: Lüdenscheid
country: Germany
facility: Lüdenscheid hospital
city: Mainz
country: Germany
facility: Mainz Uni
city: München
country: Germany
facility: München Innenstadt
city: Remscheid
country: Germany
facility: Remscheid hospital
city: Ulm
country: Germany
facility: Ulm Uni
city: Chieti
country: Italy
facility: Clinica Villa Pini d'Abruzzo
city: Conegliano
country: Italy
facility: Osp Civile di Montebelluna
city: Mestre
country: Italy
facility: Ospedale Umberto I
city: Mirano
country: Italy
facility: Presidio Ospedaliero di Mirano
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria
city: Ferrol
country: Spain
facility: Complejo Hospitalario Arquitecto Marcide
city: Madrid
country: Spain
facility: Hospital Universitario de Madrid
city: Mourente
country: Spain
facility: Hospital Montecelo
city: Salamanca
country: Spain
facility: Povisa
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico universitario de Santiago
city: Vigo
country: Spain
facility: Complejo Hospitalario Xeral-Cies
city: Ashford
country: United Kingdom
facility: William Harvey Hospital
Study officials:
affiliation: Head of Pacemaker/Defibrillator/CRT department
name: Stockburger Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: