Sinus Node DysfunctionPhase 4SAVERNCT00655213
Spontaneous Atrio Ventricular Conduction Preservation
A Phase 4 study testing Symphony D 2450 and Symphony DR 2550 in people with Sinus Node Dysfunction and Bradycardia-Tachycardia Syndrome, run by LivaNova at 67 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome, Paroxysmal Atrioventricular Block
- What is being tested?
- Symphony D 2450 and Symphony DR 2550
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 67 sitesin 5 countries
- Study dates
- Nov 2003to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
67 sites in 5 countries.
67 sites in 5 countries
Germany23 sites
Marien Hospital
Bonn
Universitätskliniken Bonn
Bonn
St.Josef-Stift Bremen
Bremen
KH Holweide
Cologne
St. Salvator Krankenhaus Halberstadt
Halberstadt
Holzminden Praxis Bub
Holzminden
Hürth Sana
Hürth
Herzzentrum Kassel
Kassel
Universitätsklinikum Schleswig-Holstein
Lübeck
Klinikum Lüdenscheid
Lüdenscheid
Städt. Kh. Lüneburg
Lüneburg
Univ. Mainz
Mainz
Univ. Marburg
Marburg
Klinkum Memmingen
Memmingen
Augustinum
München
Klinikum Bogenhausen
München
Rot-Kreuz Krankenhaus
München
Praxis Bitar
Peine
Uni Regensburg
Regensburg
Prof. Frey Praxis Starnberg
Starnberg
Uni Ulm
Ulm
Waren-Müritzklinikum
Waren
Klinikum Wolgast
Wolgast
France19 sites
Centre Hospitalier
Aix-en-Provence
CH Albi
Albi
CHU d'Angers
Angers
CHU Jean Minjoz
Besançon
CH de CASTRES
Castres-mazamet
Hospice St-Jacques-Hôspital G.Montpied
Clermont-Ferrand
CHU - Hopital Michallon
Grenoble, 38043
CHRU de Lille - Hôpital Cardiologique
Lille
CHU de Limoges
Limoges
CH Montpellier
Montpellier
CH Emile Muller
Mulhouse
CHU de Nantes
Nantes
Nouvelles Cliniques Nantaises
Nantes
CHU de Nice
Nice
Clinique Bizet
Paris, 75116
CHU Pontchaillou
Rennes
CHU Hopital C. Nicolle
Rouen, 76035
InParys Cardiology
Saint-Cloud
CHU de Nancy
Vandœuvre-lès-Nancy, 54511
Italy11 sites
Ospedale Moscati
Avellino
Ospedale Mellini
Chiari (BS)
Ospedale Civile
Conegliano (TV)
Ospedale S. G. Battista
Foligno (PG)
Ospedale Umberto I
Mestre (VE)
Ospedale Civile
Portogruaro (VE)
Istituto Policlinico
San Donato
Ospedale Civile
Sesto S. Giovanni (MI)
Ospedale Civile
Trento
Ospedale Civili Reuniti
Venezia
Ospedale Civile
Voghera
Belgium7 sites
Onze lieve Vrouw ziekenhuis
Aalst
Clinique Louis Caty
Baudour
Hôpital universitaire Brugmann
Brussels
Europa ziekenhuis
Campus Saint Elisabeth Uccle
Heiling Hart van Jezus
Moen
Hôpital Vésale (univ.)
Montigny-le-Tilleul
CHU - Tivoli
Tivoli
United Kingdom7 sites
Queen Elizabeth Hospital
Birmingham
Bristol Royal Infirmary
Bristol
Queens Hospital
Burton-on-Trent
Castle Hill Hospital
Hull
Leeds General Infirmary
Leeds
Barts and The London NHS Trust
London
St Thomas' Hospital,
London
About this study
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.
Read more
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
- Being tested
- Symphony D 2450, Symphony DR 2550
- Keywords
- Pacing, AV conduction disorders, minimized ventricular pacing, AF
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphony D 2450Device
Symphony DR 2550Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AAISafeR mode programming Receives: Device: Symphony D 2450; Device: Symphony DR 2550 |
| 2 | Active comparator | DDD with long AV Delay programming Receives: Device: Symphony D 2450; Device: Symphony DR 2550 |
| 3 | Active comparator | DDDAMC mode programming Receives: Device: Symphony D 2450; Device: Symphony DR 2550 |
| 4 | Other | AAISafer mode programming in non randomized patients Receives: Device: Symphony D 2450; Device: Symphony DR 2550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit)
Measured: 2 months
mean percentage of ventricular pacing between the studied groups during the whole study (up to 1 year).
Measured: 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.
Measured: 12 months
AF burden relatively to the branch of the protocol
Measured: 12 months
evolution of conduction disturbances by documentings nature, number and duration of ario-ventricular blocks.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startNov 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Node DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean Marc DAVY, PhD, Principal investigator, CH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655213
- Sponsor's protocol ID
- IGXD02 - SAVER
- Acronym
- SAVER
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Atrio Ventricular Conduction Preservation
- ClinicalTrials.gov ID
- NCT00655213
- Acronym / sponsor ID
- SAVER / IGXD02 - SAVER
- Conditions
- Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome, Paroxysmal Atrioventricular Block
- Keywords
- Pacing, AV conduction disorders, minimized ventricular pacing, AF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Symphony D 2450, Device: Symphony DR 2550AAISafeR mode programming |
| 2 | Active comparator | Device: Symphony D 2450, Device: Symphony DR 2550DDD with long AV Delay programming |
| 3 | Active comparator | Device: Symphony D 2450, Device: Symphony DR 2550DDDAMC mode programming |
| 4 | Other | Device: Symphony D 2450, Device: Symphony DR 2550AAISafer mode programming in non randomized patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symphony D 2450 | Device | 1, 2, 3, 4 |
| Symphony DR 2550 | Device | 1, 2, 3, 4 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Marc DAVY, PhD principal investigator
CH Montpellier
67 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Symphony D 2450 and Symphony DR 2550 in people with Sinus Node Dysfunction and Bradycardia-Tachycardia Syndrome, run by LivaNova at 67 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in Germany, France, Italy, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2008.