Sinus Node DysfunctionPRECISENCT02586480
Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode
An observational study of Sinus Node Dysfunction and Atrioventricular Block, run by LivaNova at 58 sites in France.
Trial summary
Observational study on long PR interval using the SafeR mode in bradycardia patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Dysfunction, Atrioventricular Block
- What is being tested?
- dual chamber pacemaker with SafeR algorithm
- Type of treatment
- Medical device
- How many people
- 848 participants
- Where
- 58 sitesFrance
- Study dates
- Apr 2012to Dec 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Bradycardia patients eligible for dual chamber pacemaker implantation for SND, AVBI or AVBII
Who may be able to join
- Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months.
- Since implantation, the device is programmed in SafeR mode
- Patient agreed to participate, after having received the appropriate and mandatory information
Who cannot join
- Patient contraindicated for cardiac pacing, according to current available guidelines
- Permanent atrial fibrillation
- Permanent high-degree AV block
- Patient not available for routine follow-up visits
- Patient already included in another clinical study
- Inability to understand the purpose of the study / refusal to cooperate
Show all 10Show fewer
- minor age
- Pregnancy
- Life expectancy less than 12 months
- Under guardianship
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
France58 sites
CH du Pays d'Aix
Aix-en-Provence
CH Alençon
Alençon
Cabinet Alès
Alès
hôpital Sud
Amiens
CH Annecy
Annecy
hôpital privé Antony
Antony
hôpital d'Argenteuil
Argenteuil
hôpital St André
Bordeaux
CH Bourges
Bourges
CHU Brest
Brest
Clinique Keraudren
Brest
CHU Caen
Caen
Clinique des 2 Caps
Calais
CH Chartres
Chartres
Ch Chaumont
Chaumont
Cabinet Cherbourg
Cherbourg
HIA Percy
Clamart
Hôpital L. Pasteur
Colmar
CH Corbeil Essonnes
Corbeil-Essonnes
Hopital Henri Mondor
Créteil
Cabinet Creutzwald
Creutzwald
CH Dinan
Dinan
CH Douarnenez
Douarnenez
CH Evreux
Évreux
CMCO Evry
Évry
Cabinet Forbach
Forbach
CH Forbach
Forbach
CH Haguenau
Haguenau
CH Helfaut
Helfaut
CH Lannion
Lannion
CH Le Havre
Le Havre
CMCM Le Mans
Le Mans
CMC Port Marly
Le Port-Marly
CH Lomme
Lomme
CH Lorient
Lorient
CHU La Timone
Marseille
Hôpital Nord
Marseille
Clinique Melun
Melun
CH Privé Metz
Metz
CH Montfermeil
Montfermeil
Clinique Montpellier
Montpellier
Clinique A. Paré
Nancy
NCN Nantes
Nantes
CH Orléans
Orléans
Cabinet Paris
Paris
CH St Joseph
Paris
CH Poissy St Germain
Poissy
CHU Poitiers
Poitiers
Clinique St Hilaire
Rouen
CCN St Denis
Saint-Denis
CH St Nazaire
Saint-Nazaire
CH Sens
Sens
CH St Malo
St-Malo
CH Basse Terre
Terre Basse, Guadeloupe
CH Thionville
Thionville
CH Valenciennes
Valenciennes
Cabinet Valognes
Valognes
CH Villefrance
Villefranche-sur-Saône
About this study
Official title: Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation
Observational study on long PR interval using the SafeR mode in bradycardia patients.
Read the detailed description
This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.
- Conditions
- Sinus Node Dysfunction, Atrioventricular Block
- Being tested
- dual chamber pacemaker with SafeR algorithm
- Keywords
- bradycardia
- Medical subject headings
- Sick Sinus Syndrome, Atrioventricular Block, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual chamber pacemaker with SafeR algorithmDevice
Also called Reply DR (Sorin Devices)
SafeR is an AVB management algorithm: it provides AAI pacing while continuously monitoring AV conduction, it switches to DDD when detecting AVB I, II or III, according to the following criteria: (1) AVB I: 6 long PR intervals, (2) AVB II: 3 blocked atrial events/12 cycles, (3) AVB III: 2 consecutive blocked atrial events. It switches back to AAI mode when needed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1)
This incidence will be measured using PR/AR histograms stored in the device memory
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startApr 2012
- Primary completionNov 2015
- Study completionDec 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 848 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jérôme TAIEB, MD, Principal investigator, CH du Pays d'Aix - Aix en Provence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586480
- Sponsor's protocol ID
- RBSY02
- Acronym
- PRECISE
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2015
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation
- ClinicalTrials.gov ID
- NCT02586480
- Acronym / sponsor ID
- PRECISE / RBSY02
- Conditions
- Sinus Node Dysfunction, Atrioventricular Block
- Keywords
- bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Oct 2015 (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.
Observational study on long PR interval using the SafeR mode in bradycardia patients.
Detailed description
This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bradycardia patients eligible for dual chamber pacemaker implantation for SND, AVBI or AVBII
Key inclusion criteria (3 listed)
- Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months.
- Since implantation, the device is programmed in SafeR mode
- Patient agreed to participate, after having received the appropriate and mandatory information
Key exclusion criteria (10 listed)
- Patient contraindicated for cardiac pacing, according to current available guidelines
- Permanent atrial fibrillation
- Permanent high-degree AV block
- Patient not available for routine follow-up visits
- Patient already included in another clinical study
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 |
|---|---|---|
| dual chamber pacemaker with SafeR algorithmAlso: Reply DR (Sorin Devices)SafeR is an AVB management algorithm: it provides AAI pacing while continuously monitoring AV conduction, it switches to DDD when detecting AVB I, II or III, according to the following criteria: (1) AVB I: 6 long PR intervals, (2) AVB II: 3 blocked atrial events/12 cycles, (3) AVB III: 2 consecutive blocked atrial events. It switches back to AAI mode when needed. | Device | – |
Primary outcome
Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1)
Time frame: at 12 months
This incidence will be measured using PR/AR histograms stored in the device memory
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 18 Oct 2017.
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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.
Jérôme TAIEB, MD principal investigator
CH du Pays d'Aix - Aix en Provence
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinus Node Dysfunction and Atrioventricular Block, run by LivaNova at 58 sites in France.
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 3 inclusion and 10 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 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in France. 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.
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?
Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1) (time frame: at 12 months). 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 18 Oct 2017.