Spontaneous Atrio Ventricular Conduction Preservation (SAVER)

April 3, 2008 updated by: LivaNova

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

622

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Onze Lieve Vrouw Ziekenhuis
      • Baudour, Belgium
        • Clinique Louis Caty
      • Bruxelles, Belgium
        • Hopital Universitaire Brugmann
      • Campus st. Elisabeth Uccle, Belgium
        • Europa ziekenhuis
      • Moen, Belgium
        • Heiling Hart van Jezus
      • Montigny Le Tilleul, Belgium
        • Hôpital Vésale (univ.)
      • Tivoli, Belgium
        • CHU - Tivoli
  • France
      • Aix-en-Provence, France
        • Centre Hospitalier
      • Albi, France
        • CH Albi
      • Angers, France
        • CHU d'Angers
      • Besancon, France
        • CHU Jean Minjoz
      • Castres-mazamet, France
        • CH de Castres
      • Clermont-Ferrand, France
        • Hospice St-Jacques-Hôspital G.Montpied
      • Grenoble, France, 38043
        • CHU - Hopital Michallon
      • Lille, France
        • CHRU de Lille - Hopital Cardiologique
      • Limoges, France
        • chu de Limoges
      • Montpellier, France
        • CH Montpellier
      • Mulhouse, France
        • CH Emile Muller
      • Nantes, France
        • CHU de Nantes
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Nice, France
        • Chu de Nice
      • Paris cedex 16, France, 75116
        • Clinique BIZET
      • Rennes, France
        • CHU Pontchaillou
      • Rouen, France, 76035
        • CHU Hopital C. Nicolle
      • St Cloud, France
        • InParys Cardiology
      • Vandoeuvre les Nancy, France, 54511
        • Chu de Nancy
  • Germany
      • Bonn, Germany
        • Marien Hospital
      • Bonn, Germany
        • Universitatskliniken Bonn
      • Bremen, Germany
        • St.Josef-Stift Bremen
      • Halberstadt, Germany
        • St. Salvator Krankenhaus Halberstadt
      • Holzminden, Germany
        • Holzminden Praxis Bub
      • Hürth, Germany
        • Hürth Sana
      • Kassel, Germany
        • Herzzentrum Kassel
      • Koln, Germany
        • KH Holweide
      • Luedenscheid, Germany
        • Klinikum Lüdenscheid
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Lüneburg, Germany
        • Städt. Kh. Lüneburg
      • Mainz, Germany
        • Univ. Mainz
      • Marburg, Germany
        • Univ. Marburg
      • Memmingen, Germany
        • Klinkum Memmingen
      • Munchen, Germany
        • Augustinum
      • Munchen, Germany
        • Klinikum Bogenhausen
      • Munchen, Germany
        • Rot-Kreuz Krankenhaus
      • Peine, Germany
        • Praxis Bitar
      • Regensburg, Germany
        • Uni Regensburg
      • Starnberg, Germany
        • Prof. Frey Praxis Starnberg
      • Ulm, Germany
        • Uni Ulm
      • Waren, Germany
        • Waren-Müritzklinikum
      • Wolgast, Germany
        • Klinikum Wolgast
  • Italy
      • Avellino, Italy
        • Ospedale Moscati
      • Chiari (BS), Italy
        • Ospedale Mellini
      • Conegliano (TV), Italy
        • Ospedale Civile
      • Foligno (PG), Italy
        • Ospedale S. G. Battista
      • Mestre (VE), Italy
        • Ospedale Umberto I
      • Portogruaro (VE), Italy
        • Ospedale Civile
      • San Donato, Italy
        • Istituto Policlinico
      • Sesto S. Giovanni (MI), Italy
        • Ospedale Civile
      • Trento, Italy
        • Ospedale Civile
      • Venezia, Italy
        • Ospedale Civili Reuniti
      • Voghera, Italy
        • Ospedale Civile
  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • Bristol, United Kingdom
        • Bristol Royal Infirmary
      • Burton on Trent, United Kingdom
        • Queens Hospital
      • Hull, United Kingdom
        • Castle Hill Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • London, United Kingdom
        • Barts and the London NHS Trust
      • London, United Kingdom
        • St Thomas' Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
AAISafeR mode programming
Device: Symphony D 2450
Device: Symphony DR 2550
Active Comparator: 2
DDD with long AV Delay programming
Device: Symphony D 2450
Device: Symphony DR 2550
Active Comparator: 3
DDDAMC mode programming
Device: Symphony D 2450
Device: Symphony DR 2550
Other: 4
AAISafer mode programming in non randomized patients
Device: Symphony D 2450
Device: Symphony DR 2550

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit)
Time Frame: 2 months
2 months
mean percentage of ventricular pacing between the studied groups during the whole study (up to 1 year).
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of ventricular pacing two month after randomization versus the percentage reported at the end of the first month follow-up in AAIsafeR mode.
Time Frame: 12 months
12 months
AF burden relatively to the branch of the protocol
Time Frame: 12 months
12 months
evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Investigators

  • Principal Investigator: Jean Marc DAVY, PhD, CH Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2008

Last Update Submitted That Met QC Criteria

April 3, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGXD02 - SAVER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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