Sinus Node DysfunctionPhase 4NCT01170611
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
A Phase 4 study testing PACEMAKER SYMPHONY 2550 in people with Sinus Node Dysfunction and Brady Tachy Syndrome, run by LivaNova at 52 sites in 8 countries.
Trial summary
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Dysfunction, Brady Tachy Syndrome
- What is being tested?
- PACEMAKER SYMPHONY 2550
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 52 sitesin 8 countries
- Study dates
- Jul 2004to Jan 2007
- 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
- A pacemaker indication for sinus node dysfunction and/or brady-tachy syndrome OR already implanted for less than three months for the mentioned reasons and supplied with a symphony 2550 DR at time of inclusion AND
- A PR interval <250ms AND
- Documented atrial arrhythmia in the past year
- Medication for anti-arrhythmic must be stable for at least one month (2 months for amiodarone) prior to enrollment
- Patients must have less than two known cardioversions within the last year
- Patient has signed a consent form after having received the appropriate information
Who cannot join
- Need a replacement pacemaker device
- Have an unknown PR interval
- Known AV block ≥ 250 ms PR interval
- Minor and/or pregnant woman
- Patients enrolled in other clinical trials
- Patients with sustained ventricular arrhythmia
Show all 15Show fewer
- Patients with severe coronary artery disease (at the discretion of the investigator)
- Patients with advanced cardiomyopathy (at the discretion of the investigator)
- Patients who have sustained a myocardial infarction or undergone cardiac surgery within the past 30 days
- Patients with unstable angina pectoris
- Patients whose life expectancy is less than 1 year
- Patients who are unlikely to return for required follow-up visits
- Patients who present with permanent atrial arrhythmia or those who usually require cardioversion to terminate such arrhythmia and/or
- Patients whose physician plans to add or change medical treatment because of AA episodes during the follow-up period.
- Patient unable to understand the purpose of the study or refusing to cooperate
Trial locations and contacts
52 sites in 8 countries.
52 sites in 8 countries
France21 sites
CHG d'Albi
Albi, 81013
CHRU du Morvan Hôpital la Cavale Blanche
Brest, 29069
Hospice St-Jacques-Hôpital G.Montpied
Clermond-Ferrand, 63003
Hôpital Henri Mondor
Créteil, 94010
C.H.I. du Val d'Ariège
Foix, 09017
CHRU de Grenoble Hôpital Michallon
Grenoble, 38043
Polyclinique du Bois
Lille, 59003
CHU de Limoges Hôpital Dupuytren
Limoges, 87042
Clinique Clairval
Marseille, 13009
Hôpital Arnaud de Villeneuve
Montpellier, 34295
Polyclinique de Gentilly
Nancy, 54100
Nouvelles Cliniques Nantaises
Nantes, 44277
Hôpital Pasteur
Nice, 6000
Hôpital Pitié-Salpêtrière
Paris, 75013
InParys CLINIQUE BIZET
Paris, 75016
CHU Haut l'Evêque
Pessac, 33604
CHU Pontchaillou
Rennes, 35033
CHU - Hôpital Charles Nicolle
Rouen, 76031
Centre Cardiologique du Nord
Saint-Denis, 93200
Centre Hospitalier Rangueil
Toulouse, 31403
CHU Brabois
Vandœuvre-lès-Nancy, 54500
United States10 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
NorthEast Medical Center
Concord, North Carolina, 28025
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Lancaster Regional Medical Center
Lancaster, Pennsylvania, 17603
Brentwood Biomedical Research Institute
Los Angeles, California, 90073
Banner Baywood Heart Hospital
Mesa, Arizona, 85206
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Passaic Beth Israel Regional Medical Center
Passaic, New Jersey, 07055
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Hillcrest Medical Center
Tulsa, Oklahoma, 74104
Belgium8 sites
OLV Aalst
Aalst, 9300
Cliniques Sud Luxembourg
Arlon, 6700
Clinique Saint-Jean
Brussels, 1000
Algemeen Ziekenhuis Sint-Dimpna
Geel, 2440
Centre Hospitalier Hutois
Huy, 4500
CHU Tivoli
La Louvière, 7100
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, 2610
UCL Mont-Godinne
Yvoir, 5530
Germany8 sites
Hufeland Krankenhaus GmbH
Bad Langensalza, 99947
Charite Campus Virchow
Berlin, 13353
Kliniken der Stadt Köln
Cologne, D-51067
Universitätklinikum Leipzig
Leipzig, D-04103
Universitätklinik. Lübeck
Lübeck, 23538
Klinikum Lüdenscheid
Lüdenscheid, D-58515
Johannes Gutenberg-Universität - Mainz Klinikum
Mainz, D-55101
Klinikum Memmingen
Memmingen, 87700
United Kingdom2 sites
St Peters Hospital
Chertsey, Surrey, KT16 0PZ
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD
Spain1 site
Complejo Hospitalario Universitario de Vigo (CHUVI)
Pontevedra, 36204
About this study
Official title: Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
Read the detailed description
In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.
- Conditions
- Sinus Node Dysfunction, Brady Tachy Syndrome
- Being tested
- PACEMAKER SYMPHONY 2550
- 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.
PACEMAKER SYMPHONY 2550Device
| Study group | Role | What they receive |
|---|---|---|
| AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD | Experimental | Not described Receives: Device: PACEMAKER SYMPHONY 2550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial arrhythmia burden
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJul 2004
- Study completionJan 2007
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170611
- Sponsor's protocol ID
- PREFACE-IPRE03
- Other IDs
- IPRE03
- Status last verified
- Jul 2010
- First submitted
- 22 Jul 2010
- Last updated
- 27 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease
- ClinicalTrials.gov ID
- NCT01170611
- Acronym / sponsor ID
- PREFACE-IPRE03
- Conditions
- Sinus Node Dysfunction, Brady Tachy Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Jul 2010 (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.
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
Detailed description
In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD | Experimental | Device: PACEMAKER SYMPHONY 2550 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A pacemaker indication for sinus node dysfunction and/or brady-tachy syndrome OR already implanted for less than three months for the mentioned reasons and supplied with a symphony 2550 DR at time of inclusion AND
- A PR interval <250ms AND
- Documented atrial arrhythmia in the past year
- Medication for anti-arrhythmic must be stable for at least one month (2 months for amiodarone) prior to enrollment
- Patients must have less than two known cardioversions within the last year
Key exclusion criteria (15 listed)
- Need a replacement pacemaker device
- Have an unknown PR interval
- Known AV block ≥ 250 ms PR interval
- Minor and/or pregnant woman
- Patients enrolled in other clinical trials
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 |
|---|---|---|
| PACEMAKER SYMPHONY 2550 | Device | AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD |
Primary outcome
Atrial arrhythmia burden
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 27 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PACEMAKER SYMPHONY 2550 in people with Sinus Node Dysfunction and Brady Tachy Syndrome, run by LivaNova at 52 sites in 8 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 6 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 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in France, United States, Belgium, Germany, United Kingdom and 3 more countries. 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?
Atrial arrhythmia burden. 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 27 Jul 2010.