Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF
- Status
- CompletedResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥25 required; conditions: Type 2 Diabetes Mellitus (T2DM); Atrial Fibrillation (AF)
- Interventions
- Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
- Conditions
- Type 2 Diabetes Mellitus (T2DM); Atrial Fibrillation (AF)
- Phase and size
- NA · 174 participants
- Dates
- Start 2021-08-01
Primary completion 2023-12-31 - Sponsor
- Shanghai Chest Hospital (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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.at least 12 months of follow-up, beyond the initial 3-month blanking period
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.