Atrial Fibrillation (AF)Phase 4WAITNCT07275697
Waiting on Atrial Fibrillation Intervention Therapy (WAIT) Study
A Phase 4 study testing Semaglutide 2.4 mg and Standard medical treatment in people with Atrial Fibrillation (AF) and Obesity & Overweight, run by Emma Svennberg at 1 site in Sweden.
Trial summary
Atrial fibrillation (AF) is the most common heart rhythm disorder and is associated with symptoms, reduced quality of life, heart failure, stroke, and a high risk of recurrence after catheter ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Obesity & Overweight
- What is being tested?
- Semaglutide 2.4 mg and Standard medical treatment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 23 Mar 2026to 30 Dec 2028
- Phase
- Phase 4
- 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
- To be included in the trial, subjects must meet all of the following criteria:
- Provision of written informed consent prior to participation.
- Age ≥18 years.
- Scheduled for first-time catheter ablation for atrial fibrillation using a pulmonary vein isolation (PVI) technique.
- Body Mass Index (BMI) ≥30 kg/m² (obesity) OR
- BMI ≥27 kg/m² (overweight) with one or more of the following comorbidities:
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- prediabetes (defined as HbA1c 39-47 mmol/mol or fasting glucose 5,6-6,9 mmol/L),
- known diabetes type 2
- known hypertension (prior diagnosis and/or treatment with antihypertensive medication)
- new diagnosis of hypertension (according to ESC GL for hypertension: Systolic BP ≥140 mmHg and/or diastolic BP ≥ 90 mmHg based on two readings on two separate visits, OR Ambulatory BP monitoring (24h average) ≥ 130/80 mmHg)
- dyslipidemia defined as either one of the following
- Known diagnosis of hyperlipidemia or
- Treatment with lipid lowering medication
- OR either of the following:
- LDL > 3.0 mmol/l
- Total cholesterol > 5 mmol/l
- Triglycerides > 1.7 mmol/l
- HDL (< 1 mmol/l if male, < 1.2 mmol/l if female) AND/OR
- atherosclerotic cardiovascular disease (prior myocardial infarction (MI), stroke, or peripheral arterial disease with claudication and ankle-brachial index <0.85, prior revascularization, or amputation)
- obstructive sleep apnea.
- For women of childbearing potential: Inclusion after a highly sensitive negative pregnancy test and agreement to use highly effective contraception during the study period (e.g., hormonal contraception, intrauterine device, or barrier method combined with spermicide).
Who cannot join
- Morbid obesity (BMI >40 kg/m²).
- Current use of GLP-1 receptor agonist therapy or dual agonist therapy within 6 months before screening.
- Current use of DPP-IV inhibitors.
- Diabetes type 1
- Known intolerance or contraindication to semaglutide.
- History of pancreatitis or recurrent hypoglycemia.
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- Uncontrolled diabetic retinopathy
- Severe renal failure (estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m² or in dialysis)
- Severe hepatic failure (decompensated liver disease Child-Pugh class C)
- Severe cardiac failure (NYHA class IV)
- Life expectancy <12 months.
- Inability to self-administer the investigational medicinal product.
- Prior catheter ablation procedure for atrial fibrillation.
- Pregnancy, breastfeeding, or planned pregnancy during or within two months after the study period.
- Participation in another interventional clinical trial within the past 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 141 86
Emma Svennberg, 0739584822, emma.svennberg@regionstockholm.se
Ewa Molaei, +46812381692, ewa.molaei@regionstockholm.se
About this study
Atrial fibrillation (AF) is the most common heart rhythm disorder and is associated with symptoms, reduced quality of life, heart failure, stroke, and a high risk of recurrence after catheter ablation. Many patients scheduled for their first ablation are overweight or have obesity, which is one of the strongest predictors of AF recurrence. Weight loss and risk-factor management are known to improve the outcome of ablation, but lifestyle changes are often difficult to achieve in routine care.
Semaglutide (Wegovy®) is a GLP-1 receptor agonist approved in the EU for weight management. It has been shown to produce substantial and sustained weight loss and to improve metabolic and cardiovascular risk factors. Whether treatment with semaglutide before AF ablation can improve long-term rhythm outcomes has never been tested in a randomized clinical trial.
Read more
The WAIT-AF study is a randomized, open-label trial with blinded endpoint assessment. The study includes adults with AF who are scheduled for their first catheter ablation and have a BMI ≥30 kg/m², or ≥27 kg/m² with at least one additional cardiovascular risk factor (such as hypertension, diabetes and dyslipidemia). A total of 200 participants will be enrolled.
Participants are randomly assigned in a 1:1 ratio to either standard care or semaglutide (plus lifestyle advice) prior to their scheduled ablation. Semaglutide is administered according to the approved EU label with gradual dose escalation. All participants receive an implantable loop recorder (ILR) before ablation to continuously monitor heart rhythm throughout the study.
The primary objective is to determine whether semaglutide improves arrhythmia-free survival 12 months after AF ablation. Recurrence is defined as AF, atrial flutter, or atrial tachycardia lasting ≥30 seconds on continuous ILR monitoring, excluding the standard 3-month blanking period.
Secondary outcomes include weight loss, changes in blood pressure, AF symptoms, quality of life, AF burden, need for repeat ablation, hospitalizations for cardiovascular causes, and changes in metabolic risk factors. The study also evaluates safety and tolerability of semaglutide in this patient population.
The study aims to determine whether targeted weight management with semaglutide before AF ablation can improve long-term rhythm outcomes and overall cardiovascular health. If successful, this strategy may offer a new approach to optimizing treatment and improving the results of catheter ablation for patients with AF and overweight or obesity
Read the detailed description
The WAIT trial evaluates whether metabolic optimization with once-weekly semaglutide prior to catheter ablation can improve rhythm outcomes in patients with atrial fibrillation and overweight/obesity. Excess adiposity and related cardiometabolic risk factors are strongly linked to atrial structural remodeling and higher rates of post-ablation arrhythmia recurrence. Although weight reduction is recommended in guidelines, sustained lifestyle-based weight loss is often difficult to achieve. Semaglutide provides an evidence-based pharmacologic strategy for clinically meaningful weight loss and risk-factor improvement, which may enhance the effectiveness of ablation.
This randomized, open-label study allocates participants 1:1 to semaglutide plus standard of care or standard of care alone for at least three months before undergoing their first AF ablation. All participants receive routine clinical management and continuous rhythm monitoring using an implantable loop recorder for 12 months post-ablation, with blinded adjudication of rhythm outcomes. The study integrates real-world clinical practice, using only routine clinical assessments, registry data, and ILR monitoring without introducing additional invasive procedures.
The trial is designed to determine whether targeted periablation metabolic therapy can increase arrhythmia-free survival, reduce AF burden, improve symptoms and quality of life, and favourably impact cardiovascular risk profiles. Results are expected to inform the role of GLP-1 receptor agonist therapy as part of a structured periablation optimization strategy for patients with AF and overweight or obesity.
- Conditions
- Atrial Fibrillation (AF), Obesity & Overweight
- Being tested
- Semaglutide 2.4 mg, Standard medical treatment
- Keywords
- Semaglutide, Implantable Loop Recorder, Ablation, Pulmonary Vein Isolation
- Medical subject headings
- Atrial Fibrillation, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4 mgDrug
Also called Standard of care
The intervention consists of once-weekly subcutaneous semaglutide (Wegovy®), initiated at 0.25 mg and uptitrated to a target dose of 2.4 mg as tolerated, administered for at least three months prior to the participant's first planned atrial fibrillation ablation. Semaglutide is provided in pre-filled pens and used according to the approved SmPC for weight management. This intervention is uniquely characterized by pharmacological weight-loss therapy added on top of standard-of-care management, distinguishing it from the control arm, which receives identical clinical follow-up and lifestyle counselling but no GLP-1 receptor agonist. This allows evaluation of whether targeted metabolic therapy before ablation improves arrhythmia-related outcomes.
Standard medical treatmentBehavioural
Participants randomized to the standard-of-care arm receive routine clinical management for atrial fibrillation and weight-related comorbidities without GLP-1 receptor agonist therapy. Usual care may include lifestyle counselling, blood pressure and lipid management, treatment of dysglycaemia, and guideline-directed preparation for first-time catheter ablation. No trial-specific medicinal product is administered.
| Study group | Role | What they receive |
|---|---|---|
| Randomized to Semaglutide | Experimental | Participants randomized to the active arm receive once-weekly subcutaneous semaglutide (Wegovy®) initiated at 0.25 mg and uptitrated to a target dose of 2.4 mg as tolerated, according to the approved SmPC. Treatment begins ≥3 months before the planned first catheter ablation for atrial fibrillation. Participants receive structured lifestyle and weight-management advice in accordance with routine clinical practice. Receives: Drug: Semaglutide 2.4 mg; Behavioral: Standard medical treatment |
| Standard of care | Active comparator | Participants randomized to the standard-of-care arm receive routine clinical management for atrial fibrillation and weight-related comorbidities without GLP-1 receptor agonist therapy. Usual care may include lifestyle counselling, blood pressure and lipid management, treatment of dysglycaemia, and guideline-directed preparation for first-time catheter ablation. No trial-specific medicinal product is administered. Pa Receives: Behavioral: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia-free survival at 12 months after catheter ablation, excluding the 3-month blanking period, with recurrence defined as any ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds.
Arrhythmia-free survival at 12 months after catheter ablation, excluding the 3-month blanking period, with recurrence defined as any ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds.
Measured: 12 months post-ablation
Secondary outcomes (19)
Atrial fibrillation burden (%) measured by implantable loop recorder
Atrial fibrillation burden measured using continuous monitoring from an implantable loop recorder (ILR). AF burden is defined as the percentage of total monitored time spent in atrial fibrillation during each predefined assessment window.
Measured: At ablation and at 12 months post-ablation.
Per protocol analysis of the primary outcome
Assessment of arrhythmia-free survival at 12 months post-ablation in participants who completed the study without major protocol deviations. Recurrence is defined identically to the primary ITT analysis (ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds after the blanking period). This analysis evaluates the treatment effect under optimal adherence.
Measured: 12 months post-ablation
Time to first arrhythmia recurrence after the blanking period
Time from the end of the 3-month post-ablation blanking period to the first ILR-detected episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds. This endpoint evaluates the durability of rhythm control beyond the blanking period.
Measured: From month 3 to month 12 post-ablation.
Number of repeat ablations required to achieve sinus rhythm
Total number of additional catheter ablation procedures performed per participant after the index ablation in order to restore or maintain sinus rhythm. This endpoint compares the need for redo ablations between the intervention and standard-of-care groups.
Measured: From index ablation to 12 months post-ablation.
Freedom from symptomatic AF without redo ablation
Proportion of participants who remain free from symptomatic atrial fibrillation, atrial flutter, or atrial tachycardia without requiring a repeat ablation procedure. Symptomatic episodes are defined by patient-reported symptoms corroborated by rhythm documentation. This endpoint evaluates clinically meaningful rhythm control without the need for additional invasive therapy.
Measured: From index ablation to 12 months post-ablation.
Symptom burden using questionnaires at baseline, ablation, 12 months
Assessment of atrial fibrillation-related symptom burden and functional impact using the AFEQT and AFSS validated questionnaires. Changes in symptom and quality-of-life scores will be compared between groups to evaluate improvement over time. Each questionnaire will be reported as a separate score.
Measured: At baseline, at the time of ablation, and at 12 months post-ablation
Quality of life changes using RAND-36
Assessment of changes in health-related quality of life using the RAND-36 questionnaire. A clinically meaningful change is defined as an improvement of approximately 3-5 points in any RAND-36 domain. This endpoint evaluates the impact of the intervention on physical, emotional, and functional well-being over time.
Measured: At baseline, at the time of ablation, and at 12 months post-ablation.
Weight reduction and BMI category at follow-up
Body weight (kg) and height (cm) will be measured using standard clinical equipment.
Height and weight will be combined to calculate Body Mass Index (BMI) in kg/m², which will be the single reported value for this outcome.
The endpoint is the proportion of participants who meet either of the following criteria:
≥10% reduction in baseline body weight (kg)
BMI <27 kg/m² (kg/m²)
Only the derived values (weight change % and BMI) are reported for this outcome; height and weight are not reported as separate outcome measures
Measured: At the time of ablation and at 12 months post-ablation.
Blood pressure reduction
Change in systolic blood pressure in mmHg compared with baseline, and diastolic blood pressure in mmHg. The secondary outcome will focus on the proportion of participants achieving >10% blood pressure reduction in either systolic or diastolic blood pressure. Systolic and diastolic blood pressure will be reported separately in mmHg. Measurements are performed using standardized clinical procedures to evaluate the intervention's impact on blood pressure control.
Measured: At baseline, at the time of ablation, and at 12 months post-ablation.
Change in routine clinical blood biomarkers
Changes in individual blood biomarkers measured as part of routine clinical care, including:
Fasting glucose (mmol/L; standard chemistry assay)
HbA1c (mmol/mol; HPLC/immunoassay)
Serum creatinine (µmol/L; enzymatic/Jaffe assay)
NT-proBNP (ng/L; immunoassay)
Each biomarker will be analysed separately using its native unit of measure. Descriptive only.
No study-specific blood sampling is performed.
Measured: At routine clinical assessments nearest to baseline, ablation, and 12 months post-ablation.
Complications during and after the ablation procedure
Incidence of procedure-related complications occurring during the catheter ablation or within the post-procedural follow-up period. Events may include vascular complications, pericardial effusion, tamponade, stroke/TIA, transient arrhythmias, anesthesia-related events, or other clinically relevant adverse outcomes, as documented in medical records. This endpoint compares procedural safety between study groups.
Measured: During the ablation procedure and through 12 months post ablation.
Left ventricular ejection fraction (LV-EF) pre- and post-ablation
Assessment of changes in left ventricular ejection fraction from before to after the ablation procedure, based solely on echocardiograms performed as part of routine clinical care. No study-specific imaging is required; data will be included only for participants who undergo a post-ablation echocardiogram in standard practice. This endpoint evaluates whether the intervention influences cardiac function over time.
Measured: At routine clinical echocardiography closest to baseline and the post-ablation assessment (up to 12 months).
Prevalence of diabetes, renal failure, and heart failure
Assessment of the proportion of participants with diabetes, renal failure, or heart failure using information from routine clinical care, medical records, and linked registry data. No study-specific testing is performed. This endpoint describes baseline comorbidity burden and identifies new or worsening diagnoses captured through standard care or registries.
Measured: At baseline and at 12 months post-ablation (via clinical records and registry data).
Cardiovascular hospitalization
Incidence of hospitalizations due to cardiovascular causes, identified through routine clinical records and national or regional registry data. Events may include admissions for arrhythmias, heart failure, acute coronary syndromes, or other cardiovascular conditions. No study-specific assessments are required.
Measured: From index ablation to 12 months post-ablation.
All-cause hospitalization
Incidence of hospital admissions for any cause, identified through routine clinical records and national or regional registry data. This endpoint evaluates the broader healthcare impact of the intervention beyond cardiovascular events. No study-specific assessments are required.
Measured: From index ablation to 12 months post-ablation.
Change in antiarrhythmic drug use
Assessment of initiation, discontinuation, or dose changes in antiarrhythmic medications (e.g., class I or III agents, beta-blockers) based on routine clinical records. This endpoint evaluates differences in pharmacologic rhythm control requirements between groups.
Measured: From baseline to 12 months post-ablation.
Ablation procedure duration
Total duration of the catheter ablation procedure, extracted from routine procedural reports. This endpoint evaluates whether pre-ablation metabolic optimization influences procedural complexity.
Measured: During the index ablation procedure.
Fluoroscopy time and radiation dose
Total fluoroscopy exposure time and radiation dose recorded during the index ablation procedure, as documented in routine procedural logs. This endpoint assesses potential differences in radiation exposure related to patient characteristics or weight loss. Fluoroscopy time (minutes) and radiation dose (mGy or mGy·cm²) will be reported as separate values.
Measured: During the index ablation procedure.
Healthcare utilization
Assessment of overall healthcare use, including outpatient cardiology visits, emergency department visits, and telephone/remote consultations. Data will be obtained from routine clinical records and linked regional or national healthcare registries. This endpoint evaluates whether the intervention affects healthcare demand and resource use. No study-specific visits or assessments are required.
Measured: From randomization to 12 months post-ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start23 Mar 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emma Svennberg
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor-investigator, Emma Svennberg, Karolinska University Hospital
- Investigators
- Emma Svennberg, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275697
- Sponsor's protocol ID
- WAIT
- Other IDs
- 2025-524182-25-00, 2025
- Acronym
- WAIT
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to GDPR and national data protection regulations, the use of identifiable clinical and registry-linked data, and the absence of a fully anonymised IPD-sharing infrastructure. Data will only be accessible to authorised study personnel and regulatory bodies as required. Summary results will be published in accordance with scientific and ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waiting on Atrial Fibrillation Intervention Therapy (WAIT) Study
- ClinicalTrials.gov ID
- NCT07275697
- Acronym / sponsor ID
- WAIT / WAIT
- Conditions
- Atrial Fibrillation (AF), Obesity & Overweight
- Keywords
- Semaglutide, Implantable Loop Recorder, Ablation, Pulmonary Vein Isolation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Emma SvennbergUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 Dec 2025 (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.
Atrial fibrillation (AF) is the most common heart rhythm disorder and is associated with symptoms, reduced quality of life, heart failure, stroke, and a high risk of recurrence after catheter ablation. Many patients scheduled for their first ablation are overweight or have obesity, which is one of the strongest predictors of AF recurrence. Weight loss and risk-factor management are known to improve the outcome of ablation, but lifestyle changes are often difficult to achieve in routine care.
Semaglutide (Wegovy®) is a GLP-1 receptor agonist approved in the EU for weight management. It has been shown to produce substantial and sustained weight loss and to improve metabolic and cardiovascular risk factors. Whether treatment with semaglutide before AF ablation can improve long-term rhythm outcomes has never been tested in a randomized clinical trial.
The WAIT-AF study is a randomized, open-label trial with blinded endpoint assessment. The study includes adults with AF who are scheduled for their first catheter ablation and have a BMI ≥30 kg/m², or ≥27 kg/m² with at least one additional cardiovascular risk factor (such as hypertension, diabetes and dyslipidemia). A total of 200 participants will be enrolled.
Participants are randomly assigned in a 1:1 ratio to either standard care or semaglutide (plus lifestyle advice) prior to their scheduled ablation. Semaglutide is administered according to the approved EU label with gradual dose escalation. All participants receive an implantable loop recorder (ILR) before ablation to continuously monitor heart rhythm throughout the study.
The primary objective is to determine whether semaglutide improves arrhythmia-free survival 12 months after AF ablation. Recurrence is defined as AF, atrial flutter, or atrial tachycardia lasting ≥30 seconds on continuous ILR monitoring, excluding the standard 3-month blanking period.
Secondary outcomes include weight loss, changes in blood pressure, AF symptoms, quality of life, AF burden, need for repeat ablation, hospitalizations for cardiovascular causes, and changes in metabolic risk factors. The study also evaluates safety and tolerability of semaglutide in this patient population.
The study aims to determine whether targeted weight management with semaglutide before AF ablation can improve long-term rhythm outcomes and overall cardiovascular health. If successful, this strategy may offer a new approach to optimizing treatment and improving the results of catheter ablation for patients with AF and overweight or obesity
Detailed description
The WAIT trial evaluates whether metabolic optimization with once-weekly semaglutide prior to catheter ablation can improve rhythm outcomes in patients with atrial fibrillation and overweight/obesity. Excess adiposity and related cardiometabolic risk factors are strongly linked to atrial structural remodeling and higher rates of post-ablation arrhythmia recurrence. Although weight reduction is recommended in guidelines, sustained lifestyle-based weight loss is often difficult to achieve. Semaglutide provides an evidence-based pharmacologic strategy for clinically meaningful weight loss and risk-factor improvement, which may enhance the effectiveness of ablation.
This randomized, open-label study allocates participants 1:1 to semaglutide plus standard of care or standard of care alone for at least three months before undergoing their first AF ablation. All participants receive routine clinical management and continuous rhythm monitoring using an implantable loop recorder for 12 months post-ablation, with blinded adjudication of rhythm outcomes. The study integrates real-world clinical practice, using only routine clinical assessments, registry data, and ILR monitoring without introducing additional invasive procedures.
The trial is designed to determine whether targeted periablation metabolic therapy can increase arrhythmia-free survival, reduce AF burden, improve symptoms and quality of life, and favourably impact cardiovascular risk profiles. Results are expected to inform the role of GLP-1 receptor agonist therapy as part of a structured periablation optimization strategy for patients with AF and overweight or obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized to Semaglutide | Experimental | Drug: Semaglutide 2.4 mg, Behavioral: Standard medical treatmentParticipants randomized to the active arm receive once-weekly subcutaneous semaglutide (Wegovy®) initiated at 0.25 mg and uptitrated to a target dose of 2.4 mg as tolerated, according to the approved SmPC. Treatment begins ≥3 months before the planned first catheter ablation for atrial fibrillation. Participants receive structured lifestyle and weight-management advice in accordance with routine clinical practice. |
| Standard of care | Active comparator | Behavioral: Standard medical treatmentParticipants randomized to the standard-of-care arm receive routine clinical management for atrial fibrillation and weight-related comorbidities without GLP-1 receptor agonist therapy. Usual care may include lifestyle counselling, blood pressure and lipid management, treatment of dysglycaemia, and guideline-directed preparation for first-time catheter ablation. No trial-specific medicinal product is administered. Pa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provision of written informed consent prior to participation.
- Age ≥18 years.
- Scheduled for first-time catheter ablation for atrial fibrillation using a pulmonary vein isolation (PVI) technique.
- Body Mass Index (BMI) ≥30 kg/m² (obesity) OR
- For women of childbearing potential: Inclusion after a highly sensitive negative pregnancy test and agreement to use highly effective contraception during the study period (e.g., hormonal contraception, intrauterine device, or barrier method combined with spermicide).
Key exclusion criteria (15 listed)
- Morbid obesity (BMI >40 kg/m²).
- Current use of GLP-1 receptor agonist therapy or dual agonist therapy within 6 months before screening.
- Current use of DPP-IV inhibitors.
- Diabetes type 1
- Known intolerance or contraindication to semaglutide.
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 |
|---|---|---|
| Semaglutide 2.4 mgAlso: Standard of careThe intervention consists of once-weekly subcutaneous semaglutide (Wegovy®), initiated at 0.25 mg and uptitrated to a target dose of 2.4 mg as tolerated, administered for at least three months prior to the participant's first planned atrial fibrillation ablation. Semaglutide is provided in pre-filled pens and used according to the approved SmPC for weight management. This intervention is uniquely characterized by pharmacological weight-loss therapy added on top of standard-of-care management, distinguishing it from the control arm, which receives identical clinical follow-up and lifestyle counselling but no GLP-1 receptor agonist. This allows evaluation of whether targeted metabolic therapy before ablation improves arrhythmia-related outcomes. | Drug | Randomized to Semaglutide |
| Standard medical treatmentParticipants randomized to the standard-of-care arm receive routine clinical management for atrial fibrillation and weight-related comorbidities without GLP-1 receptor agonist therapy. Usual care may include lifestyle counselling, blood pressure and lipid management, treatment of dysglycaemia, and guideline-directed preparation for first-time catheter ablation. No trial-specific medicinal product is administered. | Behavioural | Randomized to Semaglutide, Standard of care |
Primary outcome
Arrhythmia-free survival at 12 months after catheter ablation, excluding the 3-month blanking period, with recurrence defined as any ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds.
Time frame: 12 months post-ablation
Arrhythmia-free survival at 12 months after catheter ablation, excluding the 3-month blanking period, with recurrence defined as any ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds.
19 secondary outcomes
Atrial fibrillation burden (%) measured by implantable loop recorder
Time frame: At ablation and at 12 months post-ablation.
Per protocol analysis of the primary outcome
Time frame: 12 months post-ablation
Time to first arrhythmia recurrence after the blanking period
Time frame: From month 3 to month 12 post-ablation.
Number of repeat ablations required to achieve sinus rhythm
Time frame: From index ablation to 12 months post-ablation.
Freedom from symptomatic AF without redo ablation
Time frame: From index ablation to 12 months post-ablation.
Symptom burden using questionnaires at baseline, ablation, 12 months
Time frame: At baseline, at the time of ablation, and at 12 months post-ablation
Quality of life changes using RAND-36
Time frame: At baseline, at the time of ablation, and at 12 months post-ablation.
Weight reduction and BMI category at follow-up
Time frame: At the time of ablation and at 12 months post-ablation.
Blood pressure reduction
Time frame: At baseline, at the time of ablation, and at 12 months post-ablation.
Change in routine clinical blood biomarkers
Time frame: At routine clinical assessments nearest to baseline, ablation, and 12 months post-ablation.
Complications during and after the ablation procedure
Time frame: During the ablation procedure and through 12 months post ablation.
Left ventricular ejection fraction (LV-EF) pre- and post-ablation
Time frame: At routine clinical echocardiography closest to baseline and the post-ablation assessment (up to 12 months).
Prevalence of diabetes, renal failure, and heart failure
Time frame: At baseline and at 12 months post-ablation (via clinical records and registry data).
Cardiovascular hospitalization
Time frame: From index ablation to 12 months post-ablation.
All-cause hospitalization
Time frame: From index ablation to 12 months post-ablation.
Change in antiarrhythmic drug use
Time frame: From baseline to 12 months post-ablation.
Ablation procedure duration
Time frame: During the index ablation procedure.
Fluoroscopy time and radiation dose
Time frame: During the index ablation procedure.
Healthcare utilization
Time frame: From randomization to 12 months post-ablation.
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 10 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to GDPR and national data protection regulations, the use of identifiable clinical and registry-linked data, and the absence of a fully anonymised IPD-sharing infrastructure. Data will only be accessible to authorised study personnel and regulatory bodies as required. Summary results will be published in accordance with scientific and ethical standards.
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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.
Emma Svennberg, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide 2.4 mg and Standard medical treatment in people with Atrial Fibrillation (AF) and Obesity & Overweight, run by Emma Svennberg at 1 site in Sweden.
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 21 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Emma Svennberg, MD PhD (+46739584822, emma.svennberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia-free survival at 12 months after catheter ablation, excluding the 3-month blanking period, with recurrence defined as any ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds. (time frame: 12 months post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.