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Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF
Strict Weight Management and Glycemic Control Based on Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Treatment VS. Conventional Antidiabetic Drugs for Ablation Outcomes in Overweight or Obese Patients with Type 2 Diabetes and Atrial Fibrillation
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
—
Enrollment
174
actual
Study population
Atrial fibrillation, Obesity / overweight, Type 2 diabetes
Key I/E criterion
•BMI ≥25
Primary endpoint
•Atrial-fibrillation composite (Atrial-fibrillation composite)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Age > 18 years. Symptomatic atrial fibrillation (AF) that has been ineffective or intolerable to at least one Class I or III antiarrhythmic drug.
Diagnosed with Type 2 Diabetes Mellitus. Body Mass Index (BMI) greater than 25 kg/m². Ability to understand the purpose of the trial, willingness to participate, and signing of the informed consent form.
Exclusion criteria
Permanent atrial fibrillation (failed cardioversion or episode duration >12 months).
Previous history of AF ablation treatment. History of acute coronary syndrome or percutaneous coronary intervention within 6 months prior to enrollment.
History of implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT).
History of stroke or transient ischemic attack within 6 months prior to enrollment.
Severe organic heart disease, including moderate to severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.
History of left atrial appendage occlusion or planned for one-stop AF ablation and left atrial appendage occlusion.
Pregnant, breastfeeding, or planning to become pregnant. Significant bleeding tendency precluding post-procedural systemic anticoagulation.
Contraindications to oral hypoglycemic agents such as SGLT2 inhibitors or GLP-1 receptor agonists.
Presence of left atrial thrombus identified before the procedure. Previous cardiac surgery (valve repair/replacement, coronary artery bypass grafting).
Unable to perform physical exercise due to illness or disability. Significant hyperthyroidism or hypothyroidism. Drug abuse or chronic alcoholism. Comorbidity with other serious illnesses with an expected survival less than 12 months.
Any condition that does not align with the best interest of the subject. Other conditions determined by the investigator as unsuitable for inclusion in this study, such as psychiatric disorders or psychological impairments.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
1 endpointAtrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia events lasting ≥30 seconds occurring from the end of a 3-month blanking period post-procedure up to 12 months of follow-up.
Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period
Atrial-fibrillation composite
composite event, event
componentsAtrial-fibrillation composite
Weight & body composition
1 endpointChanges in Body Mass Index (BMI) from baseline to 12 months.
Time frame:at least 12 months of follow-up, beyond the initial 3 month blanking period
BMI, change
change from baseline, improvement
Heart failure
1 endpointquality of life
Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period
NYHA class, change
categorical status, improvement
Patient-reported / QoL
5 endpointsQuality of life assessments.
Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period
descriptive, improvement
Quality of life assessments
Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period
descriptive, improvement
Quality of life assessments
Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period
descriptive, improvement
Psychological distress
Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period
change from baseline, improvement
Functional status
Time frame:at least 12 months of follow-up, beyond the initial 3 month blanking period
descriptive, improvement
Safety / tolerability / PK
1 endpointComplications associated with AF ablation and serious adverse events (such as rehospitalizations, cardiovascular rehospitalizations) occurring during the study period.
Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period
Serious AEs (any)
event count, event
componentsSerious AEs (any), All-cause hospitalization
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.