Spontaneous Atrio Ventricular Conduction Preservation
- Conditions
- Sinus Node DysfunctionBradycardia-Tachycardia SyndromeParoxysmal Atrioventricular Block
- Interventions
- Device: Symphony D 2450Device: Symphony DR 2550
- Registration Number
- NCT00655213
- Lead Sponsor
- LivaNova
- Brief Summary
In case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 622
- Patient has been primo-implanted with a Symphony™ 2550 or 2450 devices for less than 3 months
- 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
- Permanent 1st, 2nd or 3rd AV block
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Symphony D 2450 DDDAMC mode programming 1 Symphony D 2450 AAISafeR mode programming 1 Symphony DR 2550 AAISafeR mode programming 2 Symphony D 2450 DDD with long AV Delay programming 2 Symphony DR 2550 DDD with long AV Delay programming 3 Symphony DR 2550 DDDAMC mode programming 4 Symphony D 2450 AAISafer mode programming in non randomized patients 4 Symphony DR 2550 AAISafer mode programming in non randomized patients
- Primary Outcome Measures
Name Time Method mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit) 2 months mean percentage of ventricular pacing between the studied groups during the whole study (up to 1 year). 12 months
- Secondary Outcome Measures
Name Time Method percentage of ventricular pacing two month after randomization versus the percentage reported at the end of the first month follow-up in AAIsafeR mode. 12 months AF burden relatively to the branch of the protocol 12 months evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks. 12 months
Trial Locations
- Locations (63)
CHU Hopital C. Nicolle
🇫🇷Rouen, France
KH Holweide
🇩🇪Koln, Germany
Onze lieve Vrouw ziekenhuis
🇧🇪Aalst, Belgium
CH Albi
🇫🇷Albi, France
St.Josef-Stift Bremen
🇩🇪Bremen, Germany
CHU d'Angers
🇫🇷Angers, France
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
Hôpital universitaire Brugmann
🇧🇪Bruxelles, Belgium
Europa ziekenhuis
🇧🇪Campus st. Elisabeth Uccle, Belgium
CH de CASTRES
🇫🇷Castres-mazamet, France
Universitätskliniken Bonn
🇩🇪Bonn, Germany
Herzzentrum Kassel
🇩🇪Kassel, Germany
Univ. Marburg
🇩🇪Marburg, Germany
St. Salvator Krankenhaus Halberstadt
🇩🇪Halberstadt, Germany
Barts and The London NHS Trust
🇬🇧London, United Kingdom
Ospedale Umberto I
🇮🇹Mestre (VE), Italy
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Klinikum Lüdenscheid
🇩🇪Luedenscheid, Germany
Hürth Sana
🇩🇪Hürth, Germany
Rot-Kreuz Krankenhaus
🇩🇪Munchen, Germany
Praxis Bitar
🇩🇪Peine, Germany
Prof. Frey Praxis Starnberg
🇩🇪Starnberg, Germany
Klinikum Wolgast
🇩🇪Wolgast, Germany
Ospedale Moscati
🇮🇹Avellino, Italy
Univ. Mainz
🇩🇪Mainz, Germany
Klinikum Bogenhausen
🇩🇪Munchen, Germany
Uni Ulm
🇩🇪Ulm, Germany
Städt. Kh. Lüneburg
🇩🇪Lüneburg, Germany
Klinkum Memmingen
🇩🇪Memmingen, Germany
St Thomas' Hospital,
🇬🇧London, United Kingdom
Ospedale Civili Reuniti
🇮🇹Venezia, Italy
Ospedale S. G. Battista
🇮🇹Foligno (PG), Italy
Queens Hospital
🇬🇧Burton on Trent, United Kingdom
Centre Hospitalier
🇫🇷Aix-en-Provence, France
CHU Jean Minjoz
🇫🇷Besancon, France
Hospice St-Jacques-Hôspital G.Montpied
🇫🇷Clermont-Ferrand, 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
CHU de Nice
🇫🇷Nice, France
CHU Pontchaillou
🇫🇷Rennes, France
InParys Cardiology
🇫🇷St Cloud, France
CHU de Nancy
🇫🇷Vandoeuvre les Nancy, France
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Uni Regensburg
🇩🇪Regensburg, Germany
CHU - Hopital Michallon
🇫🇷Grenoble, France
Marien Hospital
🇩🇪Bonn, Germany
Clinique Bizet
🇫🇷Paris cedex 16, France
Augustinum
🇩🇪Munchen, Germany
Holzminden Praxis Bub
🇩🇪Holzminden, Germany
Ospedale Civile
🇮🇹Voghera, Italy
Ospedale Mellini
🇮🇹Chiari (BS), Italy
Istituto Policlinico
🇮🇹San Donato, Italy
Waren-Müritzklinikum
🇩🇪Waren, Germany
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
CHU - Tivoli
🇧🇪Tivoli, Belgium
Hôpital Vésale (univ.)
🇧🇪Montigny Le Tilleul, Belgium
Clinique Louis Caty
🇧🇪Baudour, Belgium
Heiling Hart van Jezus
🇧🇪Moen, Belgium
Castle Hill Hospital
🇬🇧Hull, United Kingdom