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CompletedPhase NA

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

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

NCT IDNCT06660134
Org study IDSWGLP-AF

Timeline

Milestones

Study start2021-08-01actual
Primary completion2023-12-31actual
Study completion2024-01-10actual
Study first posted2024-10-28actual
Last update posted2024-10-28actual

Assets

Investigational agents

Study populations

Who this study enrolls

Atrial fibrillationObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Patient-reported / QoL
5
Cardiovascular outcomes
1
Weight & body composition
1
Heart failure
1
Safety / tolerability / PK
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint

Atrial 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 endpoint
Secondary/protocol endpoint

Changes 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 endpoint
Secondary/protocol endpoint

quality 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 endpoints
Secondary/protocol endpoint

Quality of life assessments.

Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period

descriptive, improvement

Secondary/protocol endpoint

Quality of life assessments

Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period

descriptive, improvement

Secondary/protocol endpoint

Quality of life assessments

Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period

descriptive, improvement

Secondary/protocol endpoint

Psychological distress

Time frame:at least 12 months of follow-up, beyond the initial 3-month blanking period

change from baseline, improvement

Secondary/protocol endpoint

Functional status

Time frame:at least 12 months of follow-up, beyond the initial 3 month blanking period

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Complications 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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.