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Spontaneous Atrio Ventricular Conduction Preservation (SAVER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655213
First Posted: April 9, 2008
Last Update Posted: April 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
LivaNova
  Purpose

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.


Condition Intervention Phase
Sinus Node Dysfunction Bradycardia-Tachycardia Syndrome Paroxysmal Atrioventricular Block Device: Symphony D 2450 Device: Symphony DR 2550 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Spontaneous Atrio Ventricular Conduction Preservation

Resource links provided by NLM:


Further study details as provided by LivaNova:

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

Secondary Outcome Measures:
  • 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 ]
  • AF burden relatively to the branch of the protocol [ Time Frame: 12 months ]
  • evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks. [ Time Frame: 12 months ]

Enrollment: 622
Study Start Date: November 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
4
AAISafer mode programming in non randomized patients
Device: Symphony D 2450 Device: Symphony DR 2550

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655213


  Show 67 Study Locations
Sponsors and Collaborators
LivaNova
Investigators
Principal Investigator: Jean Marc DAVY, PhD CH Montpellier
  More Information

Responsible Party: J.M Davy - Principal investigator, CH Montpellier
ClinicalTrials.gov Identifier: NCT00655213     History of Changes
Other Study ID Numbers: IGXD02 - SAVER
First Submitted: April 1, 2008
First Posted: April 9, 2008
Last Update Posted: April 9, 2008
Last Verified: April 2008

Keywords provided by LivaNova:
Pacing, AV conduction disorders, minimized ventricular pacing, AF

Additional relevant MeSH terms:
Tachycardia
Bradycardia
Atrioventricular Block
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Block
Arrhythmia, Sinus