Spontaneous Atrio Ventricular Conduction Preservation

NCT00655213 | Completed Phase 4 DMC

• 1 other identifier: IGXD02 - SAVER
• Study Type: interventional
• Target: 622
• Locations: 5 countries
• Sites: 67

Brief 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.

Conditions

Sinus Node Dysfunction; Bradycardia-Tachycardia Syndrome; Paroxysmal Atrioventricular Block

Keywords

Pacing, AV conduction disorders, minimized ventricular pacing, AF

Outcome Measures

Primary Outcomes (2)

• mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit)

  2 months

• mean percentage of ventricular pacing between the studied groups during the whole study (up to 1 year).

  12 months

Secondary Outcomes (3)

• 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

• AF burden relatively to the branch of the protocol

  12 months

• evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks.

  12 months

Study Arms (4)

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

OTHER

AAISafer mode programming in non randomized patients

Device: Symphony D 2450; Device: Symphony DR 2550

Interventions

Symphony D 2450 DEVICE

1; 2; 3; 4

Symphony DR 2550 DEVICE

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LivaNova: lead

Study Sites (67)

Onze lieve Vrouw ziekenhuis

Aalst, Belgium

Location

Clinique Louis Caty

Baudour, Belgium

Location

Hôpital universitaire Brugmann

Brussels, Belgium

Location

Europa ziekenhuis

Campus Saint Elisabeth Uccle, Belgium

Location

Heiling Hart van Jezus

Moen, Belgium

Location

Hôpital Vésale (univ.)

Montigny-le-Tilleul, Belgium

Location

CHU - Tivoli

Tivoli, Belgium

Location

Centre Hospitalier

Aix-en-Provence, France

Location

CH Albi

Albi, France

Location

CHU d'Angers

Angers, France

Location

CHU Jean Minjoz

Besançon, France

Location

CH de CASTRES

Castres-mazamet, France

Location

Hospice St-Jacques-Hôspital G.Montpied

Clermont-Ferrand, France

Location

CHU - Hopital Michallon

Grenoble, 38043, France

Location

CHRU de Lille - Hôpital Cardiologique

Lille, France

Location

CHU de Limoges

Limoges, France

Location

CH Montpellier

Montpellier, France

Location

CH Emile Muller

Mulhouse, France

Location

CHU de Nantes

Nantes, France

Location

Nouvelles Cliniques Nantaises

Nantes, France

Location

CHU de Nice

Nice, France

Location

Clinique Bizet

Paris, 75116, France

Location

CHU Pontchaillou

Rennes, France

Location

CHU Hopital C. Nicolle

Rouen, 76035, France

Location

InParys Cardiology

Saint-Cloud, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Marien Hospital

Bonn, Germany

Location

Universitätskliniken Bonn

Bonn, Germany

Location

St.Josef-Stift Bremen

Bremen, Germany

Location

KH Holweide

Cologne, Germany

Location

St. Salvator Krankenhaus Halberstadt

Halberstadt, Germany

Location

Holzminden Praxis Bub

Holzminden, Germany

Location

Hürth Sana

Hürth, Germany

Location

Herzzentrum Kassel

Kassel, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, Germany

Location

Städt. Kh. Lüneburg

Lüneburg, Germany

Location

Univ. Mainz

Mainz, Germany

Location

Univ. Marburg

Marburg, Germany

Location

Klinkum Memmingen

Memmingen, Germany

Location

Augustinum

München, Germany

Location

Klinikum Bogenhausen

München, Germany

Location

Rot-Kreuz Krankenhaus

München, Germany

Location

Praxis Bitar

Peine, Germany

Location

Uni Regensburg

Regensburg, Germany

Location

Prof. Frey Praxis Starnberg

Starnberg, Germany

Location

Uni Ulm

Ulm, Germany

Location

Waren-Müritzklinikum

Waren, Germany

Location

Klinikum Wolgast

Wolgast, Germany

Location

Ospedale Moscati

Avellino, Italy

Location

Ospedale Mellini

Chiari (BS), Italy

Location

Ospedale Civile

Conegliano (TV), Italy

Location

Ospedale S. G. Battista

Foligno (PG), Italy

Location

Ospedale Umberto I

Mestre (VE), Italy

Location

Ospedale Civile

Portogruaro (VE), Italy

Location

Istituto Policlinico

San Donato, Italy

Location

Ospedale Civile

Sesto S. Giovanni (MI), Italy

Location

Ospedale Civile

Trento, Italy

Location

Ospedale Civili Reuniti

Venezia, Italy

Location

Ospedale Civile

Voghera, Italy

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Queens Hospital

Burton-on-Trent, United Kingdom

Location

Castle Hill Hospital

Hull, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Barts and The London NHS Trust

London, United Kingdom

Location

St Thomas' Hospital,

London, United Kingdom

Location

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Marc DAVY, PhD

  CH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 9, 2008
• Study Start: November 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 9, 2008

Record last verified: 2008-04

Locations

GB (7); DE (23); BE (7); FR (19); IT (11)