Atrial FibrillationPREDICT-AFNCT03130985
Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but adequate risk prediction is currently impossible. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 May 2015to 30 Sep 2020
- How long will I take part?
- 2 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients are eligible that are referred to the investigators' tertiary cardiothoracic center for mitral valve surgery, (aortic) valve surgery or coronary artery bypass surgery and meet in- and exclusion criteria.
Who may be able to join
- Elective sternotomy for either coronary artery bypass surgery or aortic (valve) surgery or mitral valve surgery
- CHA2DS2 VASC score ≥ 2
- Sinus rhythm
- Age between 18 and 80 years
- Legally competent and willing and able to sign informed consent
Who cannot join
- Unable or unwilling to comply with study procedures
- Documented or reported history of atrial fibrillation, atrial flutter (duration > 5 minutes) or ventricular tachycardia
- Emergency or redo of CABG
- Emergency valvular surgery or pericarditis or endocarditis
- NYHA class IV heart failure symptoms or left ventricular ejection fraction < 35%
- Pregnancy or of childbearing potential without adequate contraception
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- History of previous radiation therapy of the thorax
- Active malignancy
- Active inflammtion or auto-immune disease
- Surgery for congenital anomalies
- Circumstances that prevent follow-up (no permanent home or address, transient, etc.)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105AZ
About this study
Official title: PREventive Left Atrial appenDage Resection for predICtion of fuTure Atrial Fibrillation
Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but adequate risk prediction is currently impossible. This study aims to discover tissue and circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological processes underlying AF and are potential tools for risk stratification and prognosis or may become future targets of therapy.
This study will be a single-center cohort study of 150 patients undergoing cardiac surgery, which will constitute the beginning of the follow-up period. Left atrial appendages, whole blood and epicardial mappings will be collected. Patients will be followed for 2 years with regular holter investigations to detect postoperative and new-onset AF.
Read the detailed description
Study procedures:
The left atrial appendage (LAA) will be removed for research and intended prophylactic purposes, using a surgical stapler or surgical knife prior to the standard procedure. Epicardial mappings may be performed during cardiac surgery with a 48-multi-electrode. Patients will be followed with regular 24-hour Holter investigations.
This study will be an exploratory study with a required inclusion of 150 patients, based on the estimated event rate. Patients will be recruited by the investigators during pre-operative assessment.
Clinical data will be gathered at baseline and stored in a customized microsoft access entry database. Statistical analysis will be performed in collaboration with the Bioinformatics Laboratory from the Academic Medical Center.
- Conditions
- Atrial Fibrillation
- Keywords
- microRNA, biomarker
- Medical subject headings
- Atrial Fibrillation
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 |
|---|---|---|
| Cardiac surgery patients | The study cohort will comprise of patients without a history of AF that undergo cardiac surgery (CABG or mitral valve surgery) with increased CHADSVASC scores of ≥2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incident Atrial Fibrillation
A de novo 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode within 2 years after surgery (with a blanking period for the postoperative period <30 days).
Measured: within 2 years after surgery
Postoperative Atrial Fibrillation
A 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode in the first 30 days following cardiac surgery or registered at the first 24h Holter monitoring if scheduled within 6 weeks following cardiac surgery.
Measured: within the first 30 days after surgery
Secondary outcomes (1)
Quality of Life defined by 36-Item Short Form Health Survey questionnaire
The quality of life is measured by 36-Item Short Form Health Survey questionnaires.
Measured: at 6 months and 1 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 posted27 Apr 2017
- Study start12 May 2015
- Primary completion6 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- 150 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Joris de Groot, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130985
- Sponsor's protocol ID
- NL50754.018.14
- Acronym
- PREDICT-AF
- Status last verified
- Nov 2020
- First submitted
- 4 Jun 2015
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
van den Berg NWE, Neefs J, Kawasaki M, Nariswari FA, Wesselink R, Fabrizi B, Jongejan A, Klaver MN, Havenaar H, Hulsman EL, Wintgens LIS, Baalman SWE, Meulendijks ER, van Boven WJ, de Jong JSSG, van Putte BP, Driessen AHG, Boersma LVA, de Groot JR; PREDICT-AF Investigators. Extracellular matrix remodeling precedes atrial fibrillation: Results of the PREDICT-AF trial. Heart Rhythm. 2021 Dec;18(12):2115-2125. doi: 10.1016/j.hrthm.2021.07.059. Epub 2021 Jul 29.
PubMed 34332113van den Berg NWE, Neefs J, Berger WR, Boersma LVA, van Boven WJ, van Putte BP, Kaya A, Kawasaki M, Driessen AHG, de Groot JR; PREDICT AF Investigators. PREventive left atrial appenDage resection for the predICtion of fuTure atrial fibrillation: design of the PREDICT AF study. J Cardiovasc Med (Hagerstown). 2019 Nov;20(11):752-761. doi: 10.2459/JCM.0000000000000868.
PubMed 31567634
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREventive Left Atrial appenDage Resection for predICtion of fuTure Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03130985
- Acronym / sponsor ID
- PREDICT-AF / NL50754.018.14
- Conditions
- Atrial Fibrillation
- Keywords
- microRNA, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 12 May 2015 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 27 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.
Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but adequate risk prediction is currently impossible. This study aims to discover tissue and circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological processes underlying AF and are potential tools for risk stratification and prognosis or may become future targets of therapy.
This study will be a single-center cohort study of 150 patients undergoing cardiac surgery, which will constitute the beginning of the follow-up period. Left atrial appendages, whole blood and epicardial mappings will be collected. Patients will be followed for 2 years with regular holter investigations to detect postoperative and new-onset AF.
Detailed description
Study procedures:
The left atrial appendage (LAA) will be removed for research and intended prophylactic purposes, using a surgical stapler or surgical knife prior to the standard procedure. Epicardial mappings may be performed during cardiac surgery with a 48-multi-electrode. Patients will be followed with regular 24-hour Holter investigations.
This study will be an exploratory study with a required inclusion of 150 patients, based on the estimated event rate. Patients will be recruited by the investigators during pre-operative assessment.
Clinical data will be gathered at baseline and stored in a customized microsoft access entry database. Statistical analysis will be performed in collaboration with the Bioinformatics Laboratory from the Academic Medical Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | – | –The study cohort will comprise of patients without a history of AF that undergo cardiac surgery (CABG or mitral valve surgery) with increased CHADSVASC scores of ≥2. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients are eligible that are referred to the investigators' tertiary cardiothoracic center for mitral valve surgery, (aortic) valve surgery or coronary artery bypass surgery and meet in- and exclusion criteria.
Key inclusion criteria (5 listed)
- Elective sternotomy for either coronary artery bypass surgery or aortic (valve) surgery or mitral valve surgery
- CHA2DS2 VASC score ≥ 2
- Sinus rhythm
- Age between 18 and 80 years
- Legally competent and willing and able to sign informed consent
Key exclusion criteria (11 listed)
- Unable or unwilling to comply with study procedures
- Documented or reported history of atrial fibrillation, atrial flutter (duration > 5 minutes) or ventricular tachycardia
- Emergency or redo of CABG
- Emergency valvular surgery or pericarditis or endocarditis
- NYHA class IV heart failure symptoms or left ventricular ejection fraction < 35%
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
incident Atrial Fibrillation
Time frame: within 2 years after surgery
A de novo 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode within 2 years after surgery (with a blanking period for the postoperative period <30 days).
Postoperative Atrial Fibrillation
Time frame: within the first 30 days after surgery
A 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode in the first 30 days following cardiac surgery or registered at the first 24h Holter monitoring if scheduled within 6 weeks following cardiac surgery.
1 secondary outcome
Quality of Life defined by 36-Item Short Form Health Survey questionnaire
Time frame: at 6 months and 1 year follow-up
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 12 Nov 2020.
- Derived from this study: PubMed 34332113van den Berg NWE, Neefs J, Kawasaki M, Nariswari FA, Wesselink R, Fabrizi B, Jongejan A, Klaver MN, Havenaar H, Hulsman EL, Wintgens LIS, Baalman SWE, Meulendijks ER, van Boven WJ, de Jong JSSG, van Putte BP, Driessen AHG, Boersma LVA, de Groot JR; PREDICT-AF Investigators. Extracellular matrix remodeling precedes atrial fibrillation: Results of the PREDICT-AF trial. Heart Rhythm. 2021 Dec;18(12):2115-2125. doi: 10.1016/j.hrthm.2021.07.059. Epub 2021 Jul 29.
- Derived from this study: PubMed 31567634van den Berg NWE, Neefs J, Berger WR, Boersma LVA, van Boven WJ, van Putte BP, Kaya A, Kawasaki M, Driessen AHG, de Groot JR; PREDICT AF Investigators. PREventive left atrial appenDage resection for the predICtion of fuTure atrial fibrillation: design of the PREDICT AF study. J Cardiovasc Med (Hagerstown). 2019 Nov;20(11):752-761. doi: 10.2459/JCM.0000000000000868.
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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.
Joris de Groot, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 5 inclusion and 11 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 12 Nov 2020. 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?
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?
incident Atrial Fibrillation (time frame: within 2 years after surgery). The study lists 2 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 NCT03130985, which also lists 2 linked publications.
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 12 Nov 2020.