Atrial FibrillationRACE V- WP 5NCT03124576
Reappraisal of Atrial Fibrillation: RACE-V - Work Package 5
An observational study of Atrial Fibrillation, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
Trial summary
In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (AF). Also the contribution of the individual genetic background will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Implantable loop recorder
- Type of treatment
- Medical device
- How many people
- 380 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2016to Oct 2021
- 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: 380 patiënts undergoing elective open chest heart surgery.
Who may be able to join
- Age > 18 years;
- Undergoing first elective open chest cardiac surgery or surgical ablation for atrial fibrillation;
- Able and willing to sign informed consent for the registry;
- Able and willing to undergo implantation of implantable loop recorder (unless the patients has a pacemaker or implantable cardioverter-defibrillator (ICD) with atrial leads)
Who cannot join
- • Deemed unsuitable or not willing to undergo implantation of implantable loop recorder or attend follow-up visits.
- Pregnancy.
- Life expectancy of less than 2.5 years.
- History of prior cardiac surgery or ablation for atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
AZMaastricht
Maastricht, Limburg, 6229 HX
Martijn Gilbers, Drs, 0031620606559, martijn.gilbers@mumc.nl
Elham Bidar, Drs, 0031624266586, elham.bidar@mumc.nl
About this study
Official title: Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF- The Tissue Bank Project
In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (AF). Also the contribution of the individual genetic background will be investigated. Furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of AF progression in atrial tissue.
For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.
Read the detailed description
An estimated 380 patients will be included
Four patient categories will be included enabling to study patients with different stages of AF progression;
- Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group),
- Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring,
- Patients with self-terminating atrial fibrillation at inclusion, and
- Patients with non-self-terminating atrial fibrillation at inclusion. At baseline in-depth phenotyping and genotyping will be performed. Continuous rhythm monitoring will also be performed in all patients. The combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.
- Conditions
- Atrial Fibrillation
- Being tested
- Implantable loop recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable loop recorderDevice
Also called Reveal LINQ™,Medtronic, ConfirmTM, St. Jude, BiomonitorTM, Biotronik
Continuous rhythm monitoring Medtronic
| Study group | Role | What they receive |
|---|---|---|
| control group | Without history of atrial fibrillation/without newly developed atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder Receives: Device: Implantable loop recorder | |
| group B | Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder Receives: Device: Implantable loop recorder | |
| group C | Patients with self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring Receives: Device: Implantable loop recorder | |
| group D | Patients with non-self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring Receives: Device: Implantable loop recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical factors in atrial biopsies and blood samples
Biochemical factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
Measured: 2.5 year follow up
Molecular factors in atrial biopsies and blood samples
Molecular factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
Measured: 2.5 year follow up
Genetic factors in atrial biopsies and blood samples
Genetic factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
Measured: 2.5 year follow up
Secondary outcomes (7)
Atrial fibrillation burden
Atrial fibrillation burden
Measured: 2.5 year follow up
Number of atrial fibrillation episodes
Number of atrial fibrillation episodes
Measured: 2.5 year follow up
Duration of atrial fibrillation episodes
Duration of atrial fibrillation episodes
Measured: 2.5 year follow up
Major adverse cardiovascular and cerebrovascular events
Major adverse cardiovascular and cerebrovascular events (i.e. death, stroke, myocardial infarction)
Measured: 2.5 year follow up
First recurrent atrial fibrillation;
First recurrent atrial fibrillation
Measured: 2.5 year follow up
AF progression
Self-terminating atrial fibrillation turning into non-self-terminating atrial fibrillation measured from ECGs and implantable loop recorders
Measured: 2.5 year follow up
AF complexity
Electrical atrial fibrillation complexity or signs of atrial conduction disturbances measured from ECGs
Measured: 2.5 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startNov 2016
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. G. Maessen, Academisch Ziekenhuis Maastricht
- Investigators
- Jos Maessen, Prof. Dr., Principal investigator, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124576
- Sponsor's protocol ID
- NL56796.068.16
- Acronym
- RACE V- WP 5
- Status last verified
- Jul 2018
- First submitted
- 1 Nov 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gilbers MD, Kawczynski MJ, Bidar E, Maesen B, Isaacs A, Winters J, Linz D, Rienstra M, van Gelder I, Maessen JG, Schotten U. Clinical Predictors of Device-Detected Atrial Fibrillation During 2.5 Years After Cardiac Surgery: Prospective RACE V Cohort. JACC Clin Electrophysiol. 2024 May;10(5):941-955. doi: 10.1016/j.jacep.2024.01.013. Epub 2024 Mar 13.
PubMed 38483418
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF- The Tissue Bank Project
- ClinicalTrials.gov ID
- NCT03124576
- Acronym / sponsor ID
- RACE V- WP 5 / NL56796.068.16
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 24 Apr 2017 (actual)
- 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.
In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (AF). Also the contribution of the individual genetic background will be investigated. Furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of AF progression in atrial tissue.
For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.
Detailed description
An estimated 380 patients will be included
Four patient categories will be included enabling to study patients with different stages of AF progression;
- Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group),
- Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring,
- Patients with self-terminating atrial fibrillation at inclusion, and
- Patients with non-self-terminating atrial fibrillation at inclusion. At baseline in-depth phenotyping and genotyping will be performed. Continuous rhythm monitoring will also be performed in all patients. The combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | – | Device: Implantable loop recorderWithout history of atrial fibrillation/without newly developed atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder |
| group B | – | Device: Implantable loop recorderPatients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring with a an Implantable loop recorder |
| group C | – | Device: Implantable loop recorderPatients with self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring |
| group D | – | Device: Implantable loop recorderPatients with non-self-terminating atrial fibrillation at inclusion Implantable loop recorder is used for continuous rhythm monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 380 patiënts undergoing elective open chest heart surgery.
Key inclusion criteria (4 listed)
- Age > 18 years;
- Undergoing first elective open chest cardiac surgery or surgical ablation for atrial fibrillation;
- Able and willing to sign informed consent for the registry;
- Able and willing to undergo implantation of implantable loop recorder (unless the patients has a pacemaker or implantable cardioverter-defibrillator (ICD) with atrial leads)
Key exclusion criteria (4 listed)
- • Deemed unsuitable or not willing to undergo implantation of implantable loop recorder or attend follow-up visits.
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 |
|---|---|---|
| Implantable loop recorderAlso: Reveal LINQ™,Medtronic, ConfirmTM, St. Jude, BiomonitorTM, BiotronikContinuous rhythm monitoring Medtronic | Device | control group, group B, group C, group D |
Primary outcome
Biochemical factors in atrial biopsies and blood samples
Time frame: 2.5 year follow up
Biochemical factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
Molecular factors in atrial biopsies and blood samples
Time frame: 2.5 year follow up
Molecular factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
Genetic factors in atrial biopsies and blood samples
Time frame: 2.5 year follow up
Genetic factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
7 secondary outcomes
Atrial fibrillation burden
Time frame: 2.5 year follow up
Number of atrial fibrillation episodes
Time frame: 2.5 year follow up
Duration of atrial fibrillation episodes
Time frame: 2.5 year follow up
Major adverse cardiovascular and cerebrovascular events
Time frame: 2.5 year follow up
First recurrent atrial fibrillation;
Time frame: 2.5 year follow up
AF progression
Time frame: 2.5 year follow up
AF complexity
Time frame: 2.5 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Derived from this study: PubMed 38483418Gilbers MD, Kawczynski MJ, Bidar E, Maesen B, Isaacs A, Winters J, Linz D, Rienstra M, van Gelder I, Maessen JG, Schotten U. Clinical Predictors of Device-Detected Atrial Fibrillation During 2.5 Years After Cardiac Surgery: Prospective RACE V Cohort. JACC Clin Electrophysiol. 2024 May;10(5):941-955. doi: 10.1016/j.jacep.2024.01.013. Epub 2024 Mar 13.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
Jos Maessen, Prof. Dr. principal investigator
Academisch Ziekenhuis Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martijn Gilbers, Drs. (0031620606559, M.Gilbers@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical factors in atrial biopsies and blood samples (time frame: 2.5 year follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124576, which also lists 1 linked publication.
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 19 Jul 2018.