Atrial Fibrillation New OnsetPARADISENCT05255224
PARADISE: Predicting AF After Cardiac Surgery
An observational study of Atrial Fibrillation New Onset, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The PARADISE study aims to develop and validate prediction tools to identify patients at risk of Atrial Fibrillation (AF) after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Not applicable as observational study
- How many people
- 13,684 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2021to 31 May 2025
- 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 who have undergone cardiac surgery
Who may be able to join
- Patients 18 years or over
- Admitted to hospital for any cardiac surgery
Who cannot join
- Patients who have requested that their data not be used for research (e.g. NHS Opt-out)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Predicting AF After Cardiac Surgery - the PARADISE Score. A Clinical Prediction Rule for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
The PARADISE study aims to develop and validate prediction tools to identify patients at risk of Atrial Fibrillation (AF) after cardiac surgery.
Read the detailed description
Atrial Fibrillation (AF) is a common abnormal heart rhythm. AF causes the heart to beat irregularly and sometimes very rapidly. About 30-50% of patients develop AF after heart surgery. These patients stay longer on the Intensive Care Unit (ICU) after surgery, are more likely to develop complications and have a higher risk of dying. Avoiding AF is important.
Some drugs, including beta blockers and amiodarone may help prevent AF if given after surgery. However, these may also lead to complications (such as lung damage). It is therefore important to identify which patients are most likely to benefit from these treatments (i.e., where the benefits outweigh the risks). There are existing tools designed to predict the risk of suffering AF after heart surgery. However, they are unreliable and therefore not used in clinical practice. A modern, reliable risk prediction tool is needed.
The PARADISE study will develop and test new prediction tools to identify which patients are most at risk of developing AF after heart surgery. The investigators will focus our tools on those patients who most commonly develop AF, such as those who have had surgery to repair a valve or blood vessel in their heart.
To do this the investigators will:
- Review the medical literature and assemble a panel of medical experts to create a list of known factors that affect patients' risk of AF after heart surgery
- Use a large UK general practice database (CALIBER) to see whether the investigators can find new risk factors.
- Ask the expert panel to agree a list of known and new risks factors to be included in the prediction tool.
- Develop two new prediction tools using an existing American cardiac surgery database (the Partners research Database). The first will be used before surgery, the second immediately following surgery. Two models are needed as events during surgery may alter the risk of AF.
- Test how reliably our new tools predict which patients suffer AF after surgery, with data from large UK (United Kingdom) NHS (National Health Service) heart centres, one US Hospital (Brigham) and a UK clinical trial (Tight-K).
- The investigators will work with two charities (AF Alliance and StopAfib) to share our results with patients and the wider public.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Not applicable as observational study
- Keywords
- New Onset Atrial Fibrillation, Cardiac Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable as observational studyOther
Not applicable as observational study
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Patients admitted to Mass Brigham Hospitals for cardiac surgery from 1st January 1998 to 31st December 2020 Receives: Other: Not applicable as observational study | |
| Prospective | Patients admitted to Barts Health, Liverpool Heart and Chest Hospital, or Oxford University Hospitals NHS Foundation Trust for cardiac surgery between 1st October 2021 to 31st July 2023 Receives: Other: Not applicable as observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set
Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set
Measured: Within 7 days of cardiac surgery
Model calibration (intercept) to predict Atrial Fibrillation in external data set
Model calibration (intercept) to predict Atrial Fibrillation in external data set
Measured: Within 7 days of cardiac surgery
Model calibration (slope) to predict Atrial Fibrillation in external data set
Model calibration (slope) to predict Atrial Fibrillation in external data set
Measured: Within 7 days of cardiac surgery
Secondary outcomes (2)
Additional model performance metrics to predict Atrial Fibrillation in external data set
Model positive and negative predictive values, sensitivity and specificity to predict Atrial Fibrillation in external data set
Measured: Within 7 days of cardiac surgery
Candidate risk factors for inclusion in new onset atrial fibrillation prognostic models
Candidate risk factors for inclusion in new onset atrial fibrillation prognostic models, identified through Systematic literature review and analysis of the CALIBER database using statistical and machine learning methods.
For pre-operative model, the investigators will include patient information available up to the time of surgery. For the post-operative model, the investigators will also include patient information available up to 12 hours after surgery.
Measured: Within 7 days of cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Oct 2021
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (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 Fibrillation New OnsetStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Other
- Enrolment
- 13,684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- St. Bartholomew's Hospital, University College, London, Liverpool Heart and Chest Hospital NHS Foundation Trust, Brigham and Women's Hospital, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Peter Watkinson, MD, Principal investigator, University of OxfordBenjamin O'Brien, MD, Principal investigator, Deutsches Herzzentrum der Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255224
- Sponsor's protocol ID
- PID15669
- Acronym
- PARADISE
- Status last verified
- Jan 2024
- First submitted
- 7 Feb 2022
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy and legal implications.
Publications
Bedford J, Fields KG, Collins GS, Lip GYH, Clifton DA, O'Brien B, Muehlschlegel JD, Watkinson PJ, Redfern OC. Atrial fibrillation after cardiac surgery: identifying candidate predictors through a Delphi process. BMJ Open. 2024 Sep 25;14(9):e086589. doi: 10.1136/bmjopen-2024-086589.
PubMed 39322590
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting AF After Cardiac Surgery - the PARADISE Score. A Clinical Prediction Rule for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05255224
- Acronym / sponsor ID
- PARADISE / PID15669
- Conditions
- Atrial Fibrillation New Onset
- Keywords
- New Onset Atrial Fibrillation, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13,684 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- St. Bartholomew's Hospital, University College, London, Liverpool Heart and Chest Hospital NHS Foundation Trust, Brigham and Women's Hospital, Oxford University Hospitals NHS Trust
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 24 Feb 2022 (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.
The PARADISE study aims to develop and validate prediction tools to identify patients at risk of Atrial Fibrillation (AF) after cardiac surgery.
Detailed description
Atrial Fibrillation (AF) is a common abnormal heart rhythm. AF causes the heart to beat irregularly and sometimes very rapidly. About 30-50% of patients develop AF after heart surgery. These patients stay longer on the Intensive Care Unit (ICU) after surgery, are more likely to develop complications and have a higher risk of dying. Avoiding AF is important.
Some drugs, including beta blockers and amiodarone may help prevent AF if given after surgery. However, these may also lead to complications (such as lung damage). It is therefore important to identify which patients are most likely to benefit from these treatments (i.e., where the benefits outweigh the risks). There are existing tools designed to predict the risk of suffering AF after heart surgery. However, they are unreliable and therefore not used in clinical practice. A modern, reliable risk prediction tool is needed.
The PARADISE study will develop and test new prediction tools to identify which patients are most at risk of developing AF after heart surgery. The investigators will focus our tools on those patients who most commonly develop AF, such as those who have had surgery to repair a valve or blood vessel in their heart.
To do this the investigators will:
- Review the medical literature and assemble a panel of medical experts to create a list of known factors that affect patients' risk of AF after heart surgery
- Use a large UK general practice database (CALIBER) to see whether the investigators can find new risk factors.
- Ask the expert panel to agree a list of known and new risks factors to be included in the prediction tool.
- Develop two new prediction tools using an existing American cardiac surgery database (the Partners research Database). The first will be used before surgery, the second immediately following surgery. Two models are needed as events during surgery may alter the risk of AF.
- Test how reliably our new tools predict which patients suffer AF after surgery, with data from large UK (United Kingdom) NHS (National Health Service) heart centres, one US Hospital (Brigham) and a UK clinical trial (Tight-K).
- The investigators will work with two charities (AF Alliance and StopAfib) to share our results with patients and the wider public.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Other: Not applicable as observational studyPatients admitted to Mass Brigham Hospitals for cardiac surgery from 1st January 1998 to 31st December 2020 |
| Prospective | – | Other: Not applicable as observational studyPatients admitted to Barts Health, Liverpool Heart and Chest Hospital, or Oxford University Hospitals NHS Foundation Trust for cardiac surgery between 1st October 2021 to 31st July 2023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone cardiac surgery
Key inclusion criteria (2 listed)
- Patients 18 years or over
- Admitted to hospital for any cardiac surgery
Key exclusion criteria (1 listed)
- Patients who have requested that their data not be used for research (e.g. NHS Opt-out)
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 |
|---|---|---|
| Not applicable as observational studyNot applicable as observational study | Other | Prospective, Retrospective |
Primary outcome
Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set
Time frame: Within 7 days of cardiac surgery
Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set
Model calibration (intercept) to predict Atrial Fibrillation in external data set
Time frame: Within 7 days of cardiac surgery
Model calibration (intercept) to predict Atrial Fibrillation in external data set
Model calibration (slope) to predict Atrial Fibrillation in external data set
Time frame: Within 7 days of cardiac surgery
Model calibration (slope) to predict Atrial Fibrillation in external data set
2 secondary outcomes
Additional model performance metrics to predict Atrial Fibrillation in external data set
Time frame: Within 7 days of cardiac surgery
Candidate risk factors for inclusion in new onset atrial fibrillation prognostic models
Time frame: Within 7 days of cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Derived from this study: PubMed 39322590Bedford J, Fields KG, Collins GS, Lip GYH, Clifton DA, O'Brien B, Muehlschlegel JD, Watkinson PJ, Redfern OC. Atrial fibrillation after cardiac surgery: identifying candidate predictors through a Delphi process. BMJ Open. 2024 Sep 25;14(9):e086589. doi: 10.1136/bmjopen-2024-086589.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to privacy and legal implications.
Related trials for Atrial Fibrillation New Onset
Recruiting
BoxX-NoAF Clinical Trial
Post Operative Atrial Fibrillation, Atrial Fibrillation, Postoperative
Recruiting
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
Left Bundle Branch Area Pacing, Right Ventricular Pacing
RecruitingPhase 3
Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
Atrial Fibrillation New Onset
Not yet recruiting
The Effect of Ligament of Marshall Excision During Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting (MICS-CABG) on the Prevention of Postoperative New-Onset Atrial Fibrillation: A Multicenter, Prospective, Randomized, Triple-Blinded Study
Postoperative Atrial Fibrillation
Not yet recruitingObservational study
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
Atrial Fibrillation (AF), Atrial Fibrillation New Onset
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.
Peter Watkinson, MD principal investigator
University of Oxford
Benjamin O'Brien, MD principal investigator
Deutsches Herzzentrum der Charité
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 New Onset, run by University of Oxford at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 23 Jan 2025. 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 United Kingdom. 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?
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?
Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set (time frame: Within 7 days of cardiac surgery). 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 NCT05255224, 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 23 Jan 2025.