BradycardiaNCT00286858
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
An observational study of Bradycardia and Sick Sinus Syndrome, run by Boston Scientific Corporation at 40 sites in 2 countries.
Trial summary
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Sick Sinus Syndrome, Heart Block
- What is being tested?
- Insignia Ultra and Insignia AVT
- Type of treatment
- Medical device
- How many people
- 903 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Sep 2006to Dec 2010
- 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: Consecutive patients with indication for a dual chamber pacemaker and not having a complete AV-block are invited to participate.
Who may be able to join
- Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.
Who cannot join
- Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR > 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
France39 sites
CHRU- Hôpital Nord
Amiens, 80054
Clinique Cardiologique Aressy
Aressy, 64320
Clinique du Lac et d'Argonay
Argonay, 74370
CH d'Arles
Arles, 13200
Clinique Paulmy
Bayonne, 64100
CH Beauvais
Beauvais, 60021
Polyclinique Bordeaux-Cauderan
Bordeaux, 33200
Clinique des Cèdres
Brive-la-Gaillarde, 19316
CH privé St. Martin
Caen, 14050
CHI de Castres
Castres, 81100
Polyclinique Sévigné
Cesson-Sévigné, 35510
Hôpital Fontenoy
Chartres, 28000
CH Cherbourg
Cherbourg, 50000
CH DAX
Dax, 40100
CHG de Dinan
Dinan, 22100
Clinique Notre Dame
Draguignan, 83300
Polyclinique Louis Pasteur
Essey-lès-Nancy, 54271
CHG Saint Louis - SIH Eure Seine
Évreux, 27023
CHU Albert Michalon
Grenoble, 38043
Casamance
La Ciotat, 13600
CH de La Roche sur Yon
La Roche-sur-Yon, 85025
CH de Laval
Laval, 53024
Polyclinique du Bois
Lille, 59003
Hôpital Nord
Marseille, 13915
CH Emile Muller
Mulhouse, 68070
Nouvelles Cliniques Nantaises
Nantes, 44110
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
CH Nevers
Nevers, 58033
CHU Nîmes
Nîmes, 30006
Clinique A. Brillard
Nogent-sur-Marne, 94130
CHR la Source
Orléans, 45067
CHG de Pau
Pau, 64046
CH Maréchal Joffre
Perpignan, 66046
Clinique St Hilaire
Rouen, 76000
CHP de la Loire
Saint-Etienne, 42000
Clinique Belledone
Saint-Martin-d'Hères, 38400
Clinique de L'Ormeau
Tarbes, 65000
Clinique Pasteur
Toulouse, 31076
Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Clinical Observations of Automatic Algorithms for Cardiac Pacing
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.
- Conditions
- Bradycardia, Sick Sinus Syndrome, Heart Block
- Being tested
- Insignia Ultra and Insignia AVT
- Medical subject headings
- Bradycardia, Sick Sinus Syndrome, Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insignia Ultra and Insignia AVTDevice
Regular AV-Delay increase to allow for intrinsic AV conduction, if present.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing
% Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block.
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 posted6 Feb 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier THOMAS, MD, Principal investigator, Clinique Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286858
- Sponsor's protocol ID
- Beluga
- Status last verified
- Jan 2021
- First submitted
- 2 Feb 2006
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observations of Automatic Algorithms for Cardiac Pacing
- ClinicalTrials.gov ID
- NCT00286858
- Acronym / sponsor ID
- Beluga
- Conditions
- Bradycardia, Sick Sinus Syndrome, Heart Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Feb 2006 (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 study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with indication for a dual chamber pacemaker and not having a complete AV-block are invited to participate.
Key inclusion criteria (1 listed)
- Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.
Key exclusion criteria (1 listed)
- Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR > 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.
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 |
|---|---|---|
| Insignia Ultra and Insignia AVTRegular AV-Delay increase to allow for intrinsic AV conduction, if present. | Device | – |
Primary outcome
Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing
Time frame: At 12 Months
% Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block.
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 28 Jan 2021.
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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.
Olivier THOMAS, MD principal investigator
Clinique Ambroise Paré
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Sick Sinus Syndrome, run by Boston Scientific Corporation at 40 sites in 2 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 1 inclusion and 1 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France, Guadeloupe. 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?
Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing (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 28 Jan 2021.