Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.Phase 4ANSWERNCT00562107
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
A Phase 4 study testing Symphony DR 2550 and REPLY DR cardiac pacemakers in people with Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients., run by LivaNova at 37 sites in 6 countries.
Trial summary
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients. The expected benefits will be a result of the reduction of the percentage of ventricular pacing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
- What is being tested?
- Symphony DR 2550 and REPLY DR cardiac pacemakers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 37 sitesin 6 countries
- Study dates
- Dec 2007to Apr 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines.
- Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block.
- Patient implanted with a bipolar right atrial lead and a right ventricular lead
- Patient has signed a consent form after having received the appropriate information
Who cannot join
- Patient with permanent AF
- Patient suffering from sustained ventricular arrhythmias
- Patient with congenital complete heart block
- Patient with vasovagal syncope, carotid sinus syndrome
- Patient with AV node ablation
- Patient having suffered from a myocardial infarction within the last month
Show all 15Show fewer
- Patient suffering from severe aortic stenosis
- Patient suffering from unstable angina pectoris
- 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, this is < 18 years
- Patient is a pregnant woman
- Any patient with a contra-indication for the device labeling
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
France13 sites
CHU - Hopital Sud
Amiens, 80054
Centre hospitalier de Béthune
Béthune, 62408
CHU - Hopital Michallon
Grenoble, 38043
CHP Beauregard
Marseille, 13012
CHU A de Villeneuve
Montpellier, 34295
Clinique Bizet
Paris, 75116
CHU Hopital C. Nicolle
Rouen, 76035
CCN
Saint-Denis, 93207
CHU - Hopital Nord
Saint-Etienne, 42055
CHU Hautepierre
Strasbourg, 67098
Clinique Pasteur
Toulouse, 31076
CHU Hopital Trousseau
Tours, 37044
CHU de Nancy
Vandœuvre-lès-Nancy, 54511
Germany11 sites
Charite Virchow
Berlin
Bernau hospital
Bernau
Braunschweig hospital
Braunschweig, 38100
Elisabeth KH Essen
Essen, D-45138
Leipzig Uni
Leipzig, 04103
Lübeck Uni
Lübeck, D-23538
Lüdenscheid hospital
Lüdenscheid, 58515
Mainz Uni
Mainz, 55101
München Innenstadt
München, 80336
Remscheid hospital
Remscheid, 42859
Ulm Uni
Ulm, 89081
Spain6 sites
Complejo Hospitalario Arquitecto Marcide
Ferrol, 15405
Hospital Universitario de Madrid
Madrid, 28041
Hospital Montecelo
Mourente, 36071
Povisa
Salamanca
Hospital Clinico universitario de Santiago
Santiago de Compostela, 15706
Complejo Hospitalario Xeral-Cies
Vigo, 3204
Italy5 sites
Clinica Villa Pini d'Abruzzo
Chieti, 66100
Osp Civile di Montebelluna
Conegliano, 31015
Ospedale Umberto I
Mestre, 30173
Presidio Ospedaliero di Mirano
Mirano, 30035
Azienda Ospedaliera S. Maria
Terni, 05100
United States1 site
736 Cambridge Street
Brighton, Massachusetts, MA 02135
About this study
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
The expected benefits will be a result of the reduction of the percentage of ventricular pacing.
It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.
The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)
- Being tested
- Symphony DR 2550 and REPLY DR cardiac pacemakers
- Keywords
- Minimized ventricular pacing, clinical outcome, SafeR, AAIsafeR, dual chamber pacemaker therapy, % of ventricular pacing, hospitalizations, symptomatic AF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphony DR 2550 and REPLY DR cardiac pacemakersDevice
AAISafeR/SafeR ON
Symphony DR 2550 and REPLY DR cardiac pacemakersDevice
DDD(R) (SafeR OFF)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AAIsafeR /SafeR Patient randomized with the SafeR switched ON Receives: Device: Symphony DR 2550 and REPLY DR cardiac pacemakers |
| 2 | Experimental | DDD(R) mode. Patients randomized with the SafeR mode switched OFF Receives: Device: Symphony DR 2550 and REPLY DR cardiac pacemakers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)
Measured: 3 years
Secondary outcomes (1)
Evolution of paroxysmal AV blocks
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stockburger Martin, MD, Principal investigator, Head of Pacemaker/Defibrillator/CRT department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562107
- Sponsor's protocol ID
- ANSWER - IBSY02
- Other IDs
- IBSY02
- Acronym
- ANSWER
- Status last verified
- Sep 2014
- First submitted
- 20 Nov 2007
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
- ClinicalTrials.gov ID
- NCT00562107
- Acronym / sponsor ID
- ANSWER / ANSWER - IBSY02
- Keywords
- Minimized ventricular pacing, clinical outcome, SafeR, AAIsafeR, dual chamber pacemaker therapy, % of ventricular pacing, hospitalizations, symptomatic AF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Nov 2007 (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.
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
The expected benefits will be a result of the reduction of the percentage of ventricular pacing.
It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.
The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Symphony DR 2550 and REPLY DR cardiac pacemakersAAIsafeR /SafeR Patient randomized with the SafeR switched ON |
| 2 | Experimental | Device: Symphony DR 2550 and REPLY DR cardiac pacemakersDDD(R) mode. Patients randomized with the SafeR mode switched OFF |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient primo-implanted with a Symphony 2550 or Reply DR for less than 1 month according to the official guidelines.
- Patient implanted for sinus node dysfunction (including bradycardia-tachycardia syndrome) or 2nd, advanced or 3rd degree intermittent or allegedly permanent AV block.
- Patient implanted with a bipolar right atrial lead and a right ventricular lead
- Patient has signed a consent form after having received the appropriate information
Key exclusion criteria (15 listed)
- Patient with permanent AF
- Patient suffering from sustained ventricular arrhythmias
- Patient with congenital complete heart block
- Patient with vasovagal syncope, carotid sinus syndrome
- Patient with AV node ablation
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 DR 2550 and REPLY DR cardiac pacemakersAAISafeR/SafeR ON | Device | 1 |
| Symphony DR 2550 and REPLY DR cardiac pacemakersDDD(R) (SafeR OFF) | Device | 2 |
Primary outcome
The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)
Time frame: 3 years
1 secondary outcome
Evolution of paroxysmal AV blocks
Time frame: 3 years
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 29 Sep 2014.
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.
Stockburger Martin, MD principal investigator
Head of Pacemaker/Defibrillator/CRT department
37 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Symphony DR 2550 and REPLY DR cardiac pacemakers in people with Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients., run by LivaNova at 37 sites in 6 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 4 inclusion and 15 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 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Germany, Spain, Italy, United States and 1 more country. 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?
The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure) (time frame: 3 years). 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 29 Sep 2014.