Atrial FibrillationNCT01530750
READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery
An observational study of Atrial Fibrillation, run by Catharina Ziekenhuis Eindhoven at 2 sites in Netherlands.
Trial summary
Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks before the surgery. Frequency, burden, and possible risk factors will be described. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- Mar 2012to Feb 2014
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: those patients undergoing cardiac surgery.
Who may be able to join
- Undergoing non emergency surgery
- Sinus rhythm on initial visit
Who cannot join
- History of atrial fibrillation
- Internal pacemaker
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Catharina Hospital
Eindhoven
Bramer, sander.bramer@cze.nl
- Not yet recruiting
Maastricht University Medical Center
Maastricht
Bramer, sander.bramer@cze.nl
About this study
Official title: READ-POAF Pilot Study. The Use of the Reveal XT as Device for Postoperative Atrial Fibrillation Detection After Cardiac Surgery
Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks before the surgery. Frequency, burden, and possible risk factors will be described.
During the operation direct contact epicardial mapping will be performed and tissue samples will be collected to identify an electrophysiological and a structural substrate for development of AF.
Read the detailed description
Background of the study:
Postoperative atrial fibrillation (POAF) after cardiac surgery is a common (1 in 4) complication and associated with morbidity and mortality. Not all episodes of AF are noticed and detected, especially after discharge. several studies have shown high mortality in POAF patients, suggesting a progression in AF frequency.
Objective of the study:
To investigate the real incidence and burden of POAF. Afterwards a risk stratification of POAF is made. To identify a structural and electrophysiological substrate for the development of POAF and new onset AF during follow up.
Study design:
140 patients will receive a Reveal device. After 3 and 12 months data will be subtracted from the device. 100 of these patient will undergo additional mapping and tissue biopsies during operation.
Study population:
All patients undergoing cardiac surgery without a history of AF and without a pacemaker will be invited to participate in the study.
Primary study parameters/outcome of the study:
Incidence of POAF until 3 months after CABG.
Secondary study parameters/outcome of the study:
Incidence of POAF until 12 months after CABG. Determine risk factors for early and late POAF. Detect pre-operative (unnoticed) episodes of AF.
Determine a substrate for development of AF.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There is a small risk of minor complications (hemorrhage and infection of the pocket).The device can be explanted easily if necessary. Ther is a burden of the im- and explantation of the device (local anesthesia, approx. 20 minutes). Patient will have to visit the out-hospital clinic twice.
The operation will be prolonged by 30 minutes due to mapping.
- Conditions
- Atrial Fibrillation
- Keywords
- postoperative atrial fibrillation, internal loop recorder, risk factors, coronary artery bypass surgery
- 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 |
|---|---|---|
| Post cardiac surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation (AF)
frequency, frequency distribution, and burden of AF
Measured: 3 months
Secondary outcomes (1)
atrial fibrillation (AF)
frequency, frequency distribution, burden of AF, AF substrate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2014 (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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Bart van Straten, MD, PhD, Principal investigator, CZESander Bramer, MD, Study director, CZEJos Maessen, MD. PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530750
- Sponsor's protocol ID
- NL37204.060.11
- Status last verified
- Aug 2012
- First submitted
- 8 Feb 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bidar E, Zeemering S, Gilbers M, Isaacs A, Verheule S, Zink MD, Maesen B, Bramer S, Kawczynski M, Van Gelder IC, Crijns HJGM, Maessen JG, Schotten U. Clinical and electrophysiological predictors of device-detected new-onset atrial fibrillation during 3 years after cardiac surgery. Europace. 2021 Dec 7;23(12):1922-1930. doi: 10.1093/europace/euab136.
PubMed 34198338
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- READ-POAF Pilot Study. The Use of the Reveal XT as Device for Postoperative Atrial Fibrillation Detection After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01530750
- Acronym / sponsor ID
- NL37204.060.11
- Conditions
- Atrial Fibrillation
- Keywords
- postoperative atrial fibrillation, internal loop recorder, risk factors, coronary artery bypass surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 10 Feb 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.
Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks before the surgery. Frequency, burden, and possible risk factors will be described.
During the operation direct contact epicardial mapping will be performed and tissue samples will be collected to identify an electrophysiological and a structural substrate for development of AF.
Detailed description
Background of the study:
Postoperative atrial fibrillation (POAF) after cardiac surgery is a common (1 in 4) complication and associated with morbidity and mortality. Not all episodes of AF are noticed and detected, especially after discharge. several studies have shown high mortality in POAF patients, suggesting a progression in AF frequency.
Objective of the study:
To investigate the real incidence and burden of POAF. Afterwards a risk stratification of POAF is made. To identify a structural and electrophysiological substrate for the development of POAF and new onset AF during follow up.
Study design:
140 patients will receive a Reveal device. After 3 and 12 months data will be subtracted from the device. 100 of these patient will undergo additional mapping and tissue biopsies during operation.
Study population:
All patients undergoing cardiac surgery without a history of AF and without a pacemaker will be invited to participate in the study.
Primary study parameters/outcome of the study:
Incidence of POAF until 3 months after CABG.
Secondary study parameters/outcome of the study:
Incidence of POAF until 12 months after CABG. Determine risk factors for early and late POAF. Detect pre-operative (unnoticed) episodes of AF.
Determine a substrate for development of AF.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There is a small risk of minor complications (hemorrhage and infection of the pocket).The device can be explanted easily if necessary. Ther is a burden of the im- and explantation of the device (local anesthesia, approx. 20 minutes). Patient will have to visit the out-hospital clinic twice.
The operation will be prolonged by 30 minutes due to mapping.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post cardiac surgery | – | – |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- those patients undergoing cardiac surgery.
Key inclusion criteria (2 listed)
- Undergoing non emergency surgery
- Sinus rhythm on initial visit
Key exclusion criteria (2 listed)
- History of atrial fibrillation
- Internal pacemaker
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
atrial fibrillation (AF)
Time frame: 3 months
frequency, frequency distribution, and burden of AF
1 secondary outcome
atrial fibrillation (AF)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Derived from this study: PubMed 34198338Bidar E, Zeemering S, Gilbers M, Isaacs A, Verheule S, Zink MD, Maesen B, Bramer S, Kawczynski M, Van Gelder IC, Crijns HJGM, Maessen JG, Schotten U. Clinical and electrophysiological predictors of device-detected new-onset atrial fibrillation during 3 years after cardiac surgery. Europace. 2021 Dec 7;23(12):1922-1930. doi: 10.1093/europace/euab136.
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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.
Bart van Straten, MD, PhD principal investigator
CZE
Sander Bramer, MD study director
CZE
Jos Maessen, MD. PhD principal investigator
Maastricht University Medical Center
2 sites 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 Catharina Ziekenhuis Eindhoven at 2 sites 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 2 inclusion and 2 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 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sander Bramer, MD (+31402398680, sander.bramer@cze.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation (AF) (time frame: 3 months). 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 NCT01530750, 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 3 Sep 2012.