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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
622 participants
INTERVENTIONAL
2003-11-30
2006-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In addition to saving energy, the latter mode allows spontaneous ventricular activation, the haemodynamic consequences of which are, in most cases, better than those obtained with dual chamber pacing.
Recent studies as the MOST study suggest also that ventricular desynchronization imposed by right ventricular apical pacing even when AV synchrony is preserved increases the risk of atrial fibrillation in patients with SND. Similar results were already given by anterior studies (PIPAF) which, taking into account the percentage of ventricular pacing, suggested that AF prevention algorithm in combination with a preserved native conduction are efficient in reducing AF burden.
However, current practice is to implant a dual chamber pacemaker to prevent the risk of atrioventricular block (AVB) even if DDDR pacing with a fixed long AV delay was found inefficient in reducing ventricular pacing and was associated with a high risk of arrhythmias.
The Symphony 2550 cardiac pacemaker offers pacing modes that automatically switch from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, irrespective of whether or not these are accompanied by an atrial arrhythmia, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. These 2 particular modes are called the AAI SafeR and DDD/AMC (R) mode.
The main differences between both modes are that (i) AAI SafeR does not trigger any AV Delay after a sensed or paced atrial event which allows long PR intervals or even limited ventricular pauses with no switch to DDD(R), while (ii) DDD/AMC (R) is able to optimize AV Delay after switching to DDD(R) according to measured spontaneous conduction times and to provide an acceleration in case of vaso-vagal syndrome. This pacing mode has previously been assessed in clinical studies.
This study intends to demonstrate that the automatic modes switching significantly reduce the percentage of ventricular pacing in patients implanted with a spontaneous AV conduction and reduce the occurrence of atrial arrhythmias, on a mid-term follow-up period, in comparison to standard DDD pacing with long AVDelay.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
AAISafeR mode programming
Symphony D 2450
Symphony DR 2550
2
DDD with long AV Delay programming
Symphony D 2450
Symphony DR 2550
3
DDDAMC mode programming
Symphony D 2450
Symphony DR 2550
4
AAISafer mode programming in non randomized patients
Symphony D 2450
Symphony DR 2550
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Symphony D 2450
Symphony DR 2550
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient with a normal spontaneous AV conduction at rest (PR \< 250 ms)
* Patient implanted for Sinus Node Dysfunction, Braycardia-Tachycardia Syndrome, carotid sinus syndrome/ vaso vagal syndrome or paroxistic AV Block
* Patient implanted with a bipolar right-atrial lead and ventricular lead available in the local market
* Patient has signed a consent form after having received the appropriate information
Exclusion Criteria
* Patient having a medical status complying with one of the following cases
* patient suffering from sustained ventricular arrhythmias
* patient having sustained a myocardial infarction within the last month
* patient having undergone cardiac surgery within the last month
* patient suffering from severe aortic stenosis
* patient suffering from unstable angina pectoris
* patient presents with permanent atrial arrhythmias
* 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 or a pregnant woman
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LivaNova
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
CH Montpellier
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean Marc DAVY, PhD
Role: PRINCIPAL_INVESTIGATOR
CH Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Onze lieve Vrouw ziekenhuis
Aalst, , Belgium
Clinique Louis Caty
Baudour, , Belgium
Hôpital universitaire Brugmann
Brussels, , Belgium
Europa ziekenhuis
Campus Saint Elisabeth Uccle, , Belgium
Heiling Hart van Jezus
Moen, , Belgium
Hôpital Vésale (univ.)
Montigny-le-Tilleul, , Belgium
CHU - Tivoli
Tivoli, , Belgium
Centre Hospitalier
Aix-en-Provence, , France
CH Albi
Albi, , France
CHU d'Angers
Angers, , France
CHU Jean Minjoz
Besançon, , France
CH de CASTRES
Castres-mazamet, , France
Hospice St-Jacques-Hôspital G.Montpied
Clermont-Ferrand, , France
CHU - Hopital Michallon
Grenoble, , France
CHRU de Lille - Hôpital Cardiologique
Lille, , France
CHU de Limoges
Limoges, , France
CH Montpellier
Montpellier, , France
CH Emile Muller
Mulhouse, , France
CHU de Nantes
Nantes, , France
Nouvelles Cliniques Nantaises
Nantes, , France
CHU de Nice
Nice, , France
Clinique Bizet
Paris, , France
CHU Pontchaillou
Rennes, , France
CHU Hopital C. Nicolle
Rouen, , France
InParys Cardiology
Saint-Cloud, , France
CHU de Nancy
Vandœuvre-lès-Nancy, , France
Marien Hospital
Bonn, , Germany
Universitätskliniken Bonn
Bonn, , Germany
St.Josef-Stift Bremen
Bremen, , Germany
KH Holweide
Cologne, , Germany
St. Salvator Krankenhaus Halberstadt
Halberstadt, , Germany
Holzminden Praxis Bub
Holzminden, , Germany
Hürth Sana
Hürth, , Germany
Herzzentrum Kassel
Kassel, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Klinikum Lüdenscheid
Lüdenscheid, , Germany
Städt. Kh. Lüneburg
Lüneburg, , Germany
Univ. Mainz
Mainz, , Germany
Univ. Marburg
Marburg, , Germany
Klinkum Memmingen
Memmingen, , Germany
Augustinum
München, , Germany
Klinikum Bogenhausen
München, , Germany
Rot-Kreuz Krankenhaus
München, , Germany
Praxis Bitar
Peine, , Germany
Uni Regensburg
Regensburg, , Germany
Prof. Frey Praxis Starnberg
Starnberg, , Germany
Uni Ulm
Ulm, , Germany
Waren-Müritzklinikum
Waren, , Germany
Klinikum Wolgast
Wolgast, , Germany
Ospedale Moscati
Avellino, , Italy
Ospedale Mellini
Chiari (BS), , Italy
Ospedale Civile
Conegliano (TV), , Italy
Ospedale S. G. Battista
Foligno (PG), , Italy
Ospedale Umberto I
Mestre (VE), , Italy
Ospedale Civile
Portogruaro (VE), , Italy
Istituto Policlinico
San Donato, , Italy
Ospedale Civile
Sesto S. Giovanni (MI), , Italy
Ospedale Civile
Trento, , Italy
Ospedale Civili Reuniti
Venezia, , Italy
Ospedale Civile
Voghera, , Italy
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Queens Hospital
Burton-on-Trent, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Barts and The London NHS Trust
London, , United Kingdom
St Thomas' Hospital,
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IGXD02 - SAVER
Identifier Type: -
Identifier Source: org_study_id