Spontaneous Atrio Ventricular Conduction Preservation (SAVER)

This study has been completed.
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT00655213
First received: April 1, 2008
Last updated: April 3, 2008
Last verified: April 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Spontaneous Atrio Ventricular Conduction Preservation

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • mean percentage of ventricular pacing between the studied groups during the whole study (up to 1 year). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • AF burden relatively to the branch of the protocol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655213

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

No publications provided

Responsible Party: J.M Davy - Principal investigator, CH Montpellier
ClinicalTrials.gov Identifier: NCT00655213     History of Changes
Other Study ID Numbers: IGXD02 - SAVER
Study First Received: April 1, 2008
Last Updated: April 3, 2008
Health Authority: Belgium: Institutional Review Board
France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission
United Kingdom: Research Ethics Committee
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on August 26, 2014