Atrial FibrillationSuRe-AFNCT05596175
Super-Rehab: a Novel Approach to Treat Atrial Fibrillation
A study testing Super Rehab in people with Atrial Fibrillation and Overweight and Obesity, run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study proposes to evaluate the effectiveness of a novel lifestyle intervention (Super Rehab), in addition to standard care, for patients with symptomatic atrial fibrillation (AF) requiring rhythm control strategy who are overweight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Overweight and Obesity
- What is being tested?
- Super Rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Aged >18
- Symptomatic AF (paroxysmal or persistent <12-months) with a rhythm control management strategy selected including consideration of referral for a cardioversion or ablation forming part of their planned pathway
- BMI ≥27m/kg2
Who cannot join
- Prognostic coronary artery disease, defined as left main stem >50% stenosis and/or ≥ moderate disease in ≥3 major epicardial vessels requiring revascularisation.
- Unstable angina
- New York Heart Association class III/IV heart failure or severe left ventricular impairment
- Significant cardiomyopathy (as assessed by Cardiologist, e.g. hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy)
- Severe heart valve disease
- Severe hypertension (BP >180/120mmHg) despite optimising anti-hypertensive therapy
Show all 18Show fewer
- Uncontrolled arrhythmia or higher degree heart block
- History of aortic dissection
- Recent acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack (<6 months)
- Severe autonomic or peripheral neuropathy
- Significant acute or chronic renal failure that would preclude contrast use at CT
- Significant pulmonary fibrosis or interstitial lung disease (as assessed by a pulmonary physician)
- Physically unable to participate in high-intensity exercise
- Pregnancy
- Prior AF ablation
- A clinically significant ECG abnormality at the screening visit, which in the opinion of the investigators exposes the subject to risk by enrolling in the trial, including but not limited to: sustained ventricular tachycardia, high-grade atrioventricular block (second-degree Mobitz type II or third-degree heart block), evidence of acute ischemia (ST-segment elevation or depression >1 mm), or other arrhythmias deemed clinically significant by the study cardiologist.
- Participation in another intervention-based research study
- Inability to fully understand the instructions provided during the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG
About this study
Official title: Effectiveness of a Novel Intervention (Super Rehab) in Overweight Patients With Atrial Fibrillation (SuRe AF), a Randomised Controlled Trial.
This study proposes to evaluate the effectiveness of a novel lifestyle intervention (Super Rehab), in addition to standard care, for patients with symptomatic atrial fibrillation (AF) requiring rhythm control strategy who are overweight.
As the main driver behind the selection of a rhythm-control strategy for patients with AF, the primary outcome will be an improvement in AF-related symptoms with Super Rehab versus Usual Care only. Secondary outcomes will include the burden of AF, biochemical and cardiac functional and structural changes, and markers of quality-of-life and health resource use.
Read the detailed description
In this randomised controlled trial (RCT) the investigators will study the efficacy of a novel lifestyle intervention (Super Rehab), in addition to usual care, for patients with symptomatic atrial fibrillation (AF) where are a rhythm-control strategy is being employed who are overweight. Increasing evidence has shown that AF can respond to robust lifestyle change and aggressive risk factor modification, and in some case can in fact regress.
In the majority of cases, the decision to target a rhythm-control strategy for AF is based on the symptom-burden reported by the patient. This in light of the low volume of evidence suggesting any benefits of rhythm-control strategies over rate-control strategies based on prognostic clinical outcomes.
The modifiable cardiovascular (CV) risk factors that increase both CV risk and the frequency of its various forms of disease also impact the development and progression of AF. In addition, patients with multiple CV risk factors are at enhanced risk of both poorer long-term outcomes and earlier failures of traditional rhythm-control strategies.
This RCT study will involve patients who have described symptomatic AF such that their treating team have elected for a rhythm-control strategy (i.e. a combination of anti-arrhythmic therapy ± a referral for a direct current (DC) cardioversion and/or an ablation) who are also overweight (body mass index [BMI] ≥27kg/m2). The BMI criterion acts as a marker of CV risk that may respond to a lifestyle intervention, which has proved sensitive in other studies.
Participants will be randomised to either Super Rehab and Usual Care or to continue Usual Care only. Super Rehab includes a combination of 1:1 supervised high-intensity exercise, dietary advice sessions and 3-monthly clinical reviews to optimise CV risk factor management. The whole programme lasts 12 months. Participants in both arms will undergo imaging, fitness, clinical tests (including blood tests), and complete questionnaires on four occasions during the study.
The primary outcome of the study will assess the difference in AF symptom burden between the two groups. In addition, the study will assess important secondary outcomes that include change in AF burden (i.e. the amount of time spent in AF), quality-of-life and well-being, biochemical, anthropometric, blood pressure and cardiac functional and structural changes.
- Conditions
- Atrial Fibrillation, Overweight and Obesity
- Being tested
- Super Rehab
- Keywords
- Lifestyle risk reduction, Exercise, Behavior modifications, Nutrition therapy, Diet, Cardiovascular disease
- Medical subject headings
- Atrial Fibrillation, Overweight, Obesity, Risk Reduction Behavior, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super RehabBehavioural
A 12-month healthcare-delivered lifestyle intervention involving exercise, nutritional support and optimisation of AF-related clinical risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients will continue Usual Care, which will include having medication optimised for adequate heart-rate control, anti-arrhythmic therapy, and anti-coagulation (for stroke-risk) instituted by their treating Cardiologist if indicated by their CHA₂DS₂-VASc Score. Patients who remain significantly symptomatic despite attempts to optimise medical therapy may be referred for further rhythm management strategies, including cardioversion(s) and/or ablation(s) - as per current standard clinical practice. The Cardiologist will also provide routine, verbal one-off lifestyle advice in line with guidance. |
| Super Rehab plus Usual Care | Experimental | 12-month Super Rehab programme involving supervised dietary review sessions, 1-to-1 high-intensity exercise sessions and 3-monthly clinical review of AF risk factors, alongside Usual Care (defined above) Receives: Behavioral: Super Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom burden, as defined by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
As the primary outcome, an atrial fibrillation-specific measure of symptoms and quality of life will be assessed using the University of Toronto Atrial Fibrillation Severity Scale (AFSS) questionnaire. Scores range from 0 to 35, with higher scores indicating greater AF symptom severity. Differences between groups will be assessed at 12 months, with additional assessments conducted and reported at 6- and 15-month time points.
Measured: Month 12
Secondary outcomes (21)
% burden of AF
Differences between groups of the AF burden - defined as the duration of time spent in atrial fibrillation, as assessed via implantable cardiac monitor (ICM) - will be assessed at 12 months, with additional measurements conducted and reported at 6- and 15-month time points.
Measured: Month 12
Duration and number of AF episodes
Differences between groups in AF duration and frequency will be assessed at 12 months, via implantable cardiac monitor (ICM), with additional measurements conducted and reported at 6- and 15-month time points.
Measured: Month 12
Time to first arrhythmia recurrence
Defined as the time from normal rhythm to the earliest documented date of AF, recorded via implantable cardiac monitor (ICM), following a DCCV or ablation where ICM data was available prior to the intervention.
Measured: Month 12
Anthropometrics - Body weight
Change in weight between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points.
Measured: 12 months
Anthropometrics - body mass index
Change in body mass index (BMI) between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- 15-month time points.
Measured: Month 12
Anthropometrics - abdominal waist circumference
Change in abdominal waist circumference between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- 15-month time points.
Measured: Month 12
Cardiorespiratory fitness
Differences between groups of the measured maximum rate of oxygen consumption attainable during physical exertion (VO2 peak) will be assessed via cardio pulmonary exercise test (CPET) at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points:
Measured: Month 12
Visceral fat
Differences between groups of the measured visceral fat will be assessed at 12 months (via DEXA body composition scan), with additional evaluations conducted and reported at 6- and 15-month time points.
Measured: Month 12
Cardiac structural and functional assessment with echocardiography
Change in left atrial size and strain between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points.
Measured: Month 12
CTCA based changes in left atrial structure
Differences in peri-atrial fat volume and inflammatory signal - assessed by cardiac CT - will be evaluated between groups at 12 months
Measured: Month 12
Blood pressure control
Differences between groups in both systolic and diastolic BP control, using a 7-day home blood pressure diary, will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Measured: Month 12
Serum lipid levels
Differences between groups in serum lipid levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Measured: Month 12
Glucose control (HbA1c)
Differences between groups in serum HbA1c levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Measured: Month 12
Inflammatory marker (high-sensitivity C-reactive protein)
Differences between groups in serum CRP levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Measured: Month 12
Physical activity
Differences in physical activity between groups, as defined by the implantable cardiac monitor (ICM), will be assessed at 12 months with additional evaluations conducted and reported at 6- and 15-month time points.
Measured: 12 months
European Heart Rhythm Association (EHRA) AF-score
The EHRA AF scale ranges from 1 (no symptoms) to 4 (disabling symptoms). Differences between groups will be assessed at 12 months with additional evaluations conducted and reported at the 6- and 15 month time points.
Measured: Month 12
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
The AFEQT questionnaire involves responses to a 20-item questionnaire that are scored on a 1 to 7 Likert scale (ranging from 1: "Not at all" to 7: "Extremely"). The four subscales of AFEQT are: Symptoms, Daily activities, Treatment concern and Treatment satisfaction. Overall and subscale scores range from 0 for worst to 100 for best quality of life. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Measured: Month 12
EuroQol Group (EuroQol) EQ-5D-5L questionnaire
Patient reported health-related quality-of-life will be recorded using the EuroQol EQ-5D-5L questionnaire. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Measured: Month 12
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) questionnaire. Scores range from 0 to 21 with higher scores reflecting a higher degree of anxiety and/or depression. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at the 6- and 15-month time points.
Measured: Month 12
ICEpop CAPability measure for Adults (ICECAP-A)
The ICEpop CAPability measure for Adults (ICECAP-A) will assess holistic capability changes over time as part of a health economic assessment. Scores range from 5 to 20, with higher scores reflecting higher levels of capability. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at the 6- and 15-month time points.
Measured: Month 12
Resource-use questionnaire
A study-specific resource-use questionnaire will record health economic parameters including medication burden, primary and secondary care interactions, impact of AF on work status, and smoking status. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start3 Apr 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized to Usual Care or Super Rehab plus Usual Care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath, University of Oxford, Biotronik SE & Co. KG, RUHX (Official NHS Charity for RUH Bath)
- Responsible party
- Sponsor
- Investigators
- Ali Khavandi, Principal investigator, Royal United Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596175
- Sponsor's protocol ID
- RUH Bath NHS SR AF
- Acronym
- SuRe-AF
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for data sharing will be reviewed on an individual basis upon request to the research team.
Publications
Murphy D, Graby J, Smith T, Peacock O, Abramik J, Antoniades C, Rodrigues JCL, Thompson D, Khavandi A. Effectiveness of a novel intervention (Super Rehab) in overweight patients with atrial fibrillation (SuRe AF): protocol for a randomised controlled trial. BMJ Open. 2025 Sep 14;15(9):e103090. doi: 10.1136/bmjopen-2025-103090.
PubMed 40953861
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Intervention (Super Rehab) in Overweight Patients With Atrial Fibrillation (SuRe AF), a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05596175
- Acronym / sponsor ID
- SuRe-AF / RUH Bath NHS SR AF
- Conditions
- Atrial Fibrillation, Overweight and Obesity
- Keywords
- Lifestyle risk reduction, Exercise, Behavior modifications, Nutrition therapy, Diet, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Bath, University of Oxford, Biotronik SE & Co. KG, RUHX (Official NHS Charity for RUH Bath)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 27 Oct 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.
This study proposes to evaluate the effectiveness of a novel lifestyle intervention (Super Rehab), in addition to standard care, for patients with symptomatic atrial fibrillation (AF) requiring rhythm control strategy who are overweight.
As the main driver behind the selection of a rhythm-control strategy for patients with AF, the primary outcome will be an improvement in AF-related symptoms with Super Rehab versus Usual Care only. Secondary outcomes will include the burden of AF, biochemical and cardiac functional and structural changes, and markers of quality-of-life and health resource use.
Detailed description
In this randomised controlled trial (RCT) the investigators will study the efficacy of a novel lifestyle intervention (Super Rehab), in addition to usual care, for patients with symptomatic atrial fibrillation (AF) where are a rhythm-control strategy is being employed who are overweight. Increasing evidence has shown that AF can respond to robust lifestyle change and aggressive risk factor modification, and in some case can in fact regress.
In the majority of cases, the decision to target a rhythm-control strategy for AF is based on the symptom-burden reported by the patient. This in light of the low volume of evidence suggesting any benefits of rhythm-control strategies over rate-control strategies based on prognostic clinical outcomes.
The modifiable cardiovascular (CV) risk factors that increase both CV risk and the frequency of its various forms of disease also impact the development and progression of AF. In addition, patients with multiple CV risk factors are at enhanced risk of both poorer long-term outcomes and earlier failures of traditional rhythm-control strategies.
This RCT study will involve patients who have described symptomatic AF such that their treating team have elected for a rhythm-control strategy (i.e. a combination of anti-arrhythmic therapy ± a referral for a direct current (DC) cardioversion and/or an ablation) who are also overweight (body mass index [BMI] ≥27kg/m2). The BMI criterion acts as a marker of CV risk that may respond to a lifestyle intervention, which has proved sensitive in other studies.
Participants will be randomised to either Super Rehab and Usual Care or to continue Usual Care only. Super Rehab includes a combination of 1:1 supervised high-intensity exercise, dietary advice sessions and 3-monthly clinical reviews to optimise CV risk factor management. The whole programme lasts 12 months. Participants in both arms will undergo imaging, fitness, clinical tests (including blood tests), and complete questionnaires on four occasions during the study.
The primary outcome of the study will assess the difference in AF symptom burden between the two groups. In addition, the study will assess important secondary outcomes that include change in AF burden (i.e. the amount of time spent in AF), quality-of-life and well-being, biochemical, anthropometric, blood pressure and cardiac functional and structural changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients randomized to Usual Care or Super Rehab plus Usual Care
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will continue Usual Care, which will include having medication optimised for adequate heart-rate control, anti-arrhythmic therapy, and anti-coagulation (for stroke-risk) instituted by their treating Cardiologist if indicated by their CHA₂DS₂-VASc Score. Patients who remain significantly symptomatic despite attempts to optimise medical therapy may be referred for further rhythm management strategies, including cardioversion(s) and/or ablation(s) - as per current standard clinical practice. The Cardiologist will also provide routine, verbal one-off lifestyle advice in line with guidance. |
| Super Rehab plus Usual Care | Experimental | Behavioral: Super Rehab12-month Super Rehab programme involving supervised dietary review sessions, 1-to-1 high-intensity exercise sessions and 3-monthly clinical review of AF risk factors, alongside Usual Care (defined above) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged >18
- Symptomatic AF (paroxysmal or persistent <12-months) with a rhythm control management strategy selected including consideration of referral for a cardioversion or ablation forming part of their planned pathway
- BMI ≥27m/kg2
Key exclusion criteria (18 listed)
- Prognostic coronary artery disease, defined as left main stem >50% stenosis and/or ≥ moderate disease in ≥3 major epicardial vessels requiring revascularisation.
- Unstable angina
- New York Heart Association class III/IV heart failure or severe left ventricular impairment
- Significant cardiomyopathy (as assessed by Cardiologist, e.g. hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy)
- Severe heart valve disease
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 |
|---|---|---|
| Super RehabA 12-month healthcare-delivered lifestyle intervention involving exercise, nutritional support and optimisation of AF-related clinical risk factors. | Behavioural | Super Rehab plus Usual Care |
Primary outcome
Symptom burden, as defined by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
Time frame: Month 12
As the primary outcome, an atrial fibrillation-specific measure of symptoms and quality of life will be assessed using the University of Toronto Atrial Fibrillation Severity Scale (AFSS) questionnaire. Scores range from 0 to 35, with higher scores indicating greater AF symptom severity. Differences between groups will be assessed at 12 months, with additional assessments conducted and reported at 6- and 15-month time points.
21 secondary outcomes
% burden of AF
Time frame: Month 12
Duration and number of AF episodes
Time frame: Month 12
Time to first arrhythmia recurrence
Time frame: Month 12
Anthropometrics - Body weight
Time frame: 12 months
Anthropometrics - body mass index
Time frame: Month 12
Anthropometrics - abdominal waist circumference
Time frame: Month 12
Cardiorespiratory fitness
Time frame: Month 12
Visceral fat
Time frame: Month 12
Cardiac structural and functional assessment with echocardiography
Time frame: Month 12
CTCA based changes in left atrial structure
Time frame: Month 12
Blood pressure control
Time frame: Month 12
Serum lipid levels
Time frame: Month 12
Glucose control (HbA1c)
Time frame: Month 12
Inflammatory marker (high-sensitivity C-reactive protein)
Time frame: Month 12
Physical activity
Time frame: 12 months
European Heart Rhythm Association (EHRA) AF-score
Time frame: Month 12
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
Time frame: Month 12
EuroQol Group (EuroQol) EQ-5D-5L questionnaire
Time frame: Month 12
Hospital Anxiety and Depression Scale (HADS)
Time frame: Month 12
ICEpop CAPability measure for Adults (ICECAP-A)
Time frame: Month 12
Resource-use questionnaire
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 40953861Murphy D, Graby J, Smith T, Peacock O, Abramik J, Antoniades C, Rodrigues JCL, Thompson D, Khavandi A. Effectiveness of a novel intervention (Super Rehab) in overweight patients with atrial fibrillation (SuRe AF): protocol for a randomised controlled trial. BMJ Open. 2025 Sep 14;15(9):e103090. doi: 10.1136/bmjopen-2025-103090.
- Research team website outlining research goalsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Requests for data sharing will be reviewed on an individual basis upon request to the research team.
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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.
Ali Khavandi principal investigator
Royal United Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Rehab in people with Atrial Fibrillation and Overweight and Obesity, run by Royal United Hospitals Bath NHS Foundation Trust 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 3 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Symptom burden, as defined by the University of Toronto Atrial Fibrillation Severity Scale (AFSS) (time frame: Month 12). 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 NCT05596175, 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 12 Aug 2025.