Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
NCT ID: NCT00562107
Last Updated: 2014-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
650 participants
INTERVENTIONAL
2007-12-31
2013-04-30
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
AAIsafeR /SafeR Patient randomized with the SafeR switched ON
Symphony DR 2550 and REPLY DR cardiac pacemakers
AAISafeR/SafeR ON
2
DDD(R) mode. Patients randomized with the SafeR mode switched OFF
Symphony DR 2550 and REPLY DR cardiac pacemakers
DDD(R) (SafeR OFF)
Interventions
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Symphony DR 2550 and REPLY DR cardiac pacemakers
AAISafeR/SafeR ON
Symphony DR 2550 and REPLY DR cardiac pacemakers
DDD(R) (SafeR OFF)
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Principal Investigators
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Stockburger Martin, MD
Role: PRINCIPAL_INVESTIGATOR
Head of Pacemaker/Defibrillator/CRT department
Locations
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736 Cambridge Street
Brighton, Massachusetts, United States
CHU - Hopital Sud
Amiens, , France
Centre hospitalier de Béthune
Béthune, , France
CHU - Hopital Michallon
Grenoble, , France
CHP Beauregard
Marseille, , France
CHU A de Villeneuve
Montpellier, , France
Clinique Bizet
Paris, , France
CHU Hopital C. Nicolle
Rouen, , France
CCN
Saint-Denis, , France
CHU - Hopital Nord
Saint-Etienne, , France
CHU Hautepierre
Strasbourg, , France
Clinique Pasteur
Toulouse, , France
CHU Hopital Trousseau
Tours, , France
CHU de Nancy
Vandœuvre-lès-Nancy, , France
Charite Virchow
Berlin, , Germany
Bernau hospital
Bernau, , Germany
Braunschweig hospital
Braunschweig, , Germany
Elisabeth KH Essen
Essen, , Germany
Leipzig Uni
Leipzig, , Germany
Lübeck Uni
Lübeck, , Germany
Lüdenscheid hospital
Lüdenscheid, , Germany
Mainz Uni
Mainz, , Germany
München Innenstadt
München, , Germany
Remscheid hospital
Remscheid, , Germany
Ulm Uni
Ulm, , Germany
Clinica Villa Pini d'Abruzzo
Chieti, , Italy
Osp Civile di Montebelluna
Conegliano, , Italy
Ospedale Umberto I
Mestre, , Italy
Presidio Ospedaliero di Mirano
Mirano, , Italy
Azienda Ospedaliera S. Maria
Terni, , Italy
Complejo Hospitalario Arquitecto Marcide
Ferrol, , Spain
Hospital Universitario de Madrid
Madrid, , Spain
Hospital Montecelo
Mourente, , Spain
Povisa
Salamanca, , Spain
Hospital Clinico universitario de Santiago
Santiago de Compostela, , Spain
Complejo Hospitalario Xeral-Cies
Vigo, , Spain
William Harvey Hospital
Ashford, , United Kingdom
Countries
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Other Identifiers
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IBSY02
Identifier Type: -
Identifier Source: secondary_id
ANSWER - IBSY02
Identifier Type: -
Identifier Source: org_study_id
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