Clinical trial NCT00655213: Spontaneous Atrio Ventricular Conduction Preservation
Official title: Spontaneous Atrio Ventricular Conduction Preservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sinus Node Dysfunction
Bradycardia-Tachycardia Syndrome
Paroxysmal Atrioventricular Block
Keywords: Pacing, AV conduction disorders, minimized ventricular pacing, AF
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 622
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit)
timeFrame: 2 months
measure: mean percentage of ventricular pacing between the studied groups during the whole study (up to 1 year).
timeFrame: 12 months
Secondary outcomes:
measure: percentage of ventricular pacing two month after randomization versus the percentage reported at the end of the first month follow-up in AAIsafeR mode.
timeFrame: 12 months
measure: AF burden relatively to the branch of the protocol
timeFrame: 12 months
measure: evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks.
timeFrame: 12 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze lieve Vrouw ziekenhuis
city: Baudour
country: Belgium
facility: Clinique Louis Caty
city: Bruxelles
country: Belgium
facility: Hôpital universitaire Brugmann
city: Campus st. Elisabeth Uccle
country: Belgium
facility: Europa ziekenhuis
city: Moen
country: Belgium
facility: Heiling Hart van Jezus
city: Montigny Le Tilleul
country: Belgium
facility: Hôpital Vésale (univ.)
city: Tivoli
country: Belgium
facility: CHU - Tivoli
city: Aix-en-Provence
country: France
facility: Centre Hospitalier
city: Albi
country: France
facility: CH Albi
city: Angers
country: France
facility: CHU d'Angers
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Castres-mazamet
country: France
facility: CH de CASTRES
city: Clermont-Ferrand
country: France
facility: Hospice St-Jacques-Hôspital G.Montpied
city: Grenoble
country: France
facility: CHU - Hopital Michallon
city: Lille
country: France
facility: CHRU de Lille - Hôpital Cardiologique
city: Limoges
country: France
facility: CHU de Limoges
city: Montpellier
country: France
facility: CH Montpellier
city: Mulhouse
country: France
facility: CH Emile Muller
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nice
country: France
facility: CHU de Nice
city: Paris cedex 16
country: France
facility: Clinique Bizet
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: CHU Hopital C. Nicolle
city: St Cloud
country: France
facility: InParys Cardiology
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy
city: Bonn
country: Germany
facility: Marien Hospital
city: Bonn
country: Germany
facility: Universitätskliniken Bonn
city: Bremen
country: Germany
facility: St.Josef-Stift Bremen
city: Halberstadt
country: Germany
facility: St. Salvator Krankenhaus Halberstadt
city: Holzminden
country: Germany
facility: Holzminden Praxis Bub
city: Hürth
country: Germany
facility: Hürth Sana
city: Kassel
country: Germany
facility: Herzzentrum Kassel
city: Koln
country: Germany
facility: KH Holweide
city: Luedenscheid
country: Germany
facility: Klinikum Lüdenscheid
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Lüneburg
country: Germany
facility: Städt. Kh. Lüneburg
city: Mainz
country: Germany
facility: Univ. Mainz
city: Marburg
country: Germany
facility: Univ. Marburg
city: Memmingen
country: Germany
facility: Klinkum Memmingen
city: Munchen
country: Germany
facility: Augustinum
city: Munchen
country: Germany
facility: Klinikum Bogenhausen
city: Munchen
country: Germany
facility: Rot-Kreuz Krankenhaus
city: Peine
country: Germany
facility: Praxis Bitar
city: Regensburg
country: Germany
facility: Uni Regensburg
city: Starnberg
country: Germany
facility: Prof. Frey Praxis Starnberg
city: Ulm
country: Germany
facility: Uni Ulm
city: Waren
country: Germany
facility: Waren-Müritzklinikum
city: Wolgast
country: Germany
facility: Klinikum Wolgast
city: Avellino
country: Italy
facility: Ospedale Moscati
city: Chiari (BS)
country: Italy
facility: Ospedale Mellini
city: Conegliano (TV)
country: Italy
facility: Ospedale Civile
city: Foligno (PG)
country: Italy
facility: Ospedale S. G. Battista
city: Mestre (VE)
country: Italy
facility: Ospedale Umberto I
city: Portogruaro (VE)
country: Italy
facility: Ospedale Civile
city: San Donato
country: Italy
facility: Istituto Policlinico
city: Sesto S. Giovanni (MI)
country: Italy
facility: Ospedale Civile
city: Trento
country: Italy
facility: Ospedale Civile
city: Venezia
country: Italy
facility: Ospedale Civili Reuniti
city: Voghera
country: Italy
facility: Ospedale Civile
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Burton on Trent
country: United Kingdom
facility: Queens Hospital
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
city: London
country: United Kingdom
facility: St Thomas' Hospital,
Study officials:
affiliation: CH Montpellier
name: Jean Marc DAVY, PhD
role: PRINCIPAL_INVESTIGATOR
References: