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

Phase 4

Completed

• 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

• Registration Number: NCT00562107
• Lead Sponsor: LivaNova

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Study Start: 2007-12
• Primary Completion: 2011-03
• Study Completion: 2013-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Symphony DR 2550 and REPLY DR cardiac pacemakers	DDD(R) mode. Patients randomized with the SafeR mode switched OFF
1	Symphony DR 2550 and REPLY DR cardiac pacemakers	AAIsafeR /SafeR Patient randomized with the SafeR switched ON

Primary Outcome Measures

Name	Time	Method
The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)	3 years

Secondary Outcome Measures

Name	Time	Method
Evolution of paroxysmal AV blocks	3 years

Trial Locations

Locations (37)

Ulm Uni; 🇩🇪 Ulm, Germany

Presidio Ospedaliero di Mirano; 🇮🇹 Mirano, Italy

CCN; 🇫🇷 Saint Denis, France

Elisabeth KH Essen; 🇩🇪 Essen, Germany

Leipzig Uni; 🇩🇪 Leipzig, Germany

Lüdenscheid hospital; 🇩🇪 Lüdenscheid, Germany

CHU Hopital Trousseau; 🇫🇷 Tours, France

CHU - Hopital Sud; 🇫🇷 Amiens, France

Hospital Universitario de Madrid; 🇪🇸 Madrid, Spain

CHU - Hopital Michallon; 🇫🇷 Grenoble, France

Bernau hospital; 🇩🇪 Bernau, Germany

Braunschweig hospital; 🇩🇪 Braunschweig, Germany

Clinica Villa Pini d'Abruzzo; 🇮🇹 Chieti, Italy

Centre hospitalier de Béthune; 🇫🇷 Béthune, France

Charite Virchow; 🇩🇪 Berlin, Germany

Povisa; 🇪🇸 Salamanca, Spain

Hospital Clinico universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain

Complejo Hospitalario Xeral-Cies; 🇪🇸 Vigo, Spain

William Harvey Hospital; 🇬🇧 Ashford, United Kingdom

Complejo Hospitalario Arquitecto Marcide; 🇪🇸 Ferrol, Spain

Osp Civile di Montebelluna; 🇮🇹 Conegliano, Italy

Ospedale Umberto I; 🇮🇹 Mestre, Italy

Hospital Montecelo; 🇪🇸 Mourente, Spain

Azienda Ospedaliera S. Maria; 🇮🇹 Terni, Italy

CHP Beauregard; 🇫🇷 Marseille, France

Clinique Bizet; 🇫🇷 Paris cedex 16, France

CHU A de Villeneuve; 🇫🇷 Montpellier, France

Clinique Pasteur; 🇫🇷 Toulouse, France

CHU Hautepierre; 🇫🇷 Strasbourg, France

CHU - Hopital Nord; 🇫🇷 Saint Etienne, France

736 Cambridge Street; 🇺🇸 Brighton, Massachusetts, United States

CHU de Nancy; 🇫🇷 Vandoeuvre les Nancy, France

CHU Hopital C. Nicolle; 🇫🇷 Rouen, France

Remscheid hospital; 🇩🇪 Remscheid, Germany

Mainz Uni; 🇩🇪 Mainz, Germany

Lübeck Uni; 🇩🇪 Lübeck, Germany

München Innenstadt; 🇩🇪 München, Germany