Spontaneous Atrio Ventricular Conduction Preservation

Sinus Node Dysfunction Clinical Trial

— SAVER  

Official title:

Spontaneous Atrio Ventricular Conduction Preservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655213
• Other study ID #: IGXD02 - SAVER
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2008
• Last updated: April 3, 2008
• Start date: November 2003
• Est. completion date: December 2006

Study information

• Verified date: April 2008
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardFrance: Institutional Ethical CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Ethics CommissionUnited Kingdom: Research Ethics CommitteeItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrioventricular Block
• Bradycardia
• Bradycardia-Tachycardia Syndrome
• Paroxysmal Atrioventricular Block
• Sick Sinus Syndrome
• Sinus Node Dysfunction
• Tachycardia

Intervention

Device:
• Symphony D 2450

• Symphony DR 2550

Locations

Country	Name	City	State
Belgium	Onze lieve Vrouw ziekenhuis	Aalst
Belgium	Clinique Louis Caty	Baudour
Belgium	Hôpital universitaire Brugmann	Bruxelles
Belgium	Europa ziekenhuis	Campus st. Elisabeth Uccle
Belgium	Heiling Hart van Jezus	Moen
Belgium	Hôpital Vésale (univ.)	Montigny Le Tilleul
Belgium	CHU - Tivoli	Tivoli
France	Centre Hospitalier	Aix-en-Provence
France	CH Albi	Albi
France	CHU d'Angers	Angers
France	CHU Jean Minjoz	Besancon
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 cedex 16
France	CHU Pontchaillou	Rennes
France	CHU Hopital C. Nicolle	Rouen
France	InParys Cardiology	St Cloud
France	CHU de Nancy	Vandoeuvre les Nancy
Germany	Marien Hospital	Bonn
Germany	Universitätskliniken Bonn	Bonn
Germany	St.Josef-Stift Bremen	Bremen
Germany	St. Salvator Krankenhaus Halberstadt	Halberstadt
Germany	Holzminden Praxis Bub	Holzminden
Germany	Hürth Sana	Hürth
Germany	Herzzentrum Kassel	Kassel
Germany	KH Holweide	Koln
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Klinikum Lüdenscheid	Luedenscheid
Germany	Städt. Kh. Lüneburg	Lüneburg
Germany	Univ. Mainz	Mainz
Germany	Univ. Marburg	Marburg
Germany	Klinkum Memmingen	Memmingen
Germany	Augustinum	Munchen
Germany	Klinikum Bogenhausen	Munchen
Germany	Rot-Kreuz Krankenhaus	Munchen
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
Italy	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
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit)		2 months	No
Primary	mean percentage of ventricular pacing between the studied groups during the whole study (up to 1 year).		12 months	No
Secondary	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	No
Secondary	AF burden relatively to the branch of the protocol		12 months	No
Secondary	evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks.		12 months	No