BradyarrhythmiaOPTI-MIND 2NCT01715558
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
An observational study of Bradyarrhythmia, run by Boston Scientific Corporation at 39 sites in 9 countries.
Trial summary
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradyarrhythmia
- How many people
- 514 participants
- Where
- 39 sitesin 9 countries
- Study dates
- Feb 2013to Nov 2016
- 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: Patients implanted with permanent pacemaker with RYTHMIQ programed to ON
Who may be able to join
- Patients implanted with any of BSC dual chamber PM devices equipped with RHYTMIQ with the algorithm programed to ON based on clinical indication at the time of discharge from the hospital
- Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center
- Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
Who cannot join
- Patients with 3rd degree AV block
- Patients with permanent AF
- Patients followed up remotely with remote patient management system.
- Patients who are unable to be followed up by the participating centers for a period of two years
- Patients who have a current device implanted for more than 15 days
- Women of childbearing potential who are pregnant, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion)
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol.
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
Italy11 sites
Ospedale Cardinal Massaia
Asti
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari
Policlinico S. Orsola - Malpighi
Bologna
Pres. Osp. F. Ferrari
Casarano (LE)
Ospedale Civile San Leonardo
Castellammare di Stabia
Fondazione Toscana Gabriele Monasterio
Pisa
Ospedale Santa Maria degli Angeli
Pordenone
P.O. Santa Maria Delle Grazie
Pozzuoli
Ospedale "Misericordia e Dolce" - AZIENDA USL 4 PRATO
Prato
Azienda ospedaliera Sant'Andrea
Rome
Policlinico Tor Vergata
Rome
France8 sites
CHRU Angers
Angers
CHRU de Clermont-Ferrand
Clermont-Ferrand
CHU Grenoble - Hopital Michallon
Grenoble
Hôpital la Roche sur Yon
La Roche-sur-Yon
Service de cardiologie, CHU Nancy-Brabois
Nancy
CHU de Nantes-Hopital Laennec
Nantes
Centre Hospitalier Général de Pau
Pau
CHU Poitiers - Hôpital La Miletrie
Poitiers
Germany4 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen
Universitätsklinikum
Leipzig
St.-Marien-Hospital GmbH
Lünen
Deutsches Herzzentrum München
München
Netherlands4 sites
Ziekenhuis Gelderse Vallei
Ede
Medisch Centrum Leeuwarden
Leeuwarden
St. Elisabeth Ziekenhuis
Tilburg
Gelre Ziekenhuis Zutphen
Zutphen
Denmark3 sites
Regionshospitalet Herning
Herning
Vejle Sygehus
Vejle
Viborg Sygehus
Viborg
Spain3 sites
Hospital Universitario Infanta Cristina
Badajoz
Hospital San Pedro
Logroño
Hospital de Torrejón
Torrejón
Belgium2 sites
Ziekenhuis Oost Limburg
Genk, 3600
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
Hasselt
Slovakia2 sites
SUSCCH a.s.
Banská Bystrica
The National Institute of Cardiovascular Diseases
Bratislava
United Kingdom2 sites
Blackpool Victoria
Blackpool
Barts Health NHS Trust
London
About this study
Official title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
- Conditions
- Bradyarrhythmia
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RYTHMIQ study group | Not described | |
| Historical control from OPTI-MIND | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature compared to data from a cohort of subjects implanted with BSC PM without RYTHMIQ pooled from OPTI-MIND study.
Measured: 2 years
Secondary outcomes (1)
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics.
A multivariate model will be used to find the independent association with the combined primary endpoint, RYTHMIQ algorithm and other patient characteristics.
Variables of interests include (but are not limited to): primary pacing indication (SND vs AVB), degree of AVB, age, gender, underlying disease, use of Betablockers, history of atrial fibrillation, LVEF, NYHA class, RV lead position, type of sensors used.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradyarrhythmiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715558
- Sponsor's protocol ID
- CDM00053871 / 90942887
- Acronym
- OPTI-MIND 2
- Status last verified
- Feb 2017
- First submitted
- 15 Oct 2012
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
- ClinicalTrials.gov ID
- NCT01715558
- Acronym / sponsor ID
- OPTI-MIND 2 / CDM00053871 / 90942887
- Conditions
- Bradyarrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Oct 2012 (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 purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYTHMIQ study group | – | – |
| Historical control from OPTI-MIND | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with permanent pacemaker with RYTHMIQ programed to ON
Key inclusion criteria (3 listed)
- Patients implanted with any of BSC dual chamber PM devices equipped with RHYTMIQ with the algorithm programed to ON based on clinical indication at the time of discharge from the hospital
- Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center
- Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
Key exclusion criteria (7 listed)
- Patients with 3rd degree AV block
- Patients with permanent AF
- Patients followed up remotely with remote patient management system.
- Patients who are unable to be followed up by the participating centers for a period of two years
- Patients who have a current device implanted for more than 15 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature
Time frame: 2 years
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature compared to data from a cohort of subjects implanted with BSC PM without RYTHMIQ pooled from OPTI-MIND study.
1 secondary outcome
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics.
Time frame: 2 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 9 May 2017.
Related trials for Bradyarrhythmia
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
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.
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradyarrhythmia, run by Boston Scientific Corporation at 39 sites in 9 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 3 inclusion and 7 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Italy, France, Germany, Netherlands, Denmark and 4 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.
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?
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature (time frame: 2 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 9 May 2017.