Spontaneous Atrio Ventricular Conduction Preservation - Full Text View

Sponsored by:	Sorin Group
Information provided by:	Sorin Group
ClinicalTrials.gov Identifier:	NCT00655213

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Spontaneous Atrio Ventricular Conduction Preservation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

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
1: Active Comparator AAISafeR mode programming	Device: Symphony D 2450 Device: Symphony DR 2550
2: Active Comparator DDD with long AV Delay programming	Device: Symphony D 2450 Device: Symphony DR 2550
3: Active Comparator 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

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:	CH Montpellier ( J.M Davy - Principal investigator )
Study ID Numbers:	IGXD02 - SAVER
Study First Received:	April 1, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00655213 History of Changes
Health Authority:	Belgium: Institutional Review Board; France: Institutional Ethical Committee; France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Heart Diseases
Heart Block
Arrhythmia, Sinus
Tachycardia

Bradycardia
Atrioventricular Block
Sick Sinus Syndrome
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Disease
Pathologic Processes
Heart Diseases
Heart Block
Arrhythmia, Sinus
Tachycardia

Syndrome
Bradycardia
Cardiovascular Diseases
Atrioventricular Block
Sick Sinus Syndrome
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 09, 2009