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Not yet recruiting NCT07389941

Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation

Phase IV Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Semaglutide (SEMA).
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation (SPICE-AF)

Overview

To evaluate whether pre-treatment with semaglutide is superior to standard care in improving freedom from atrial fibrillation (AF) at 12 months following catheter ablation in patients with obesity and symptomatic AF undergoing first-time ablation.

Interventions

  • Drug Semaglutide (SEMA)
    Catheter ablation for AF plus semaglutide (up to 2.4 mg weekly)

Primary outcome measures

  • Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Age 18-80 years
  • Symptomatic paroxysmal or persistent AF eligible for first-time catheter ablation
  • Body mass index ≥30 kg/m or body mass index ≥28 kg/m plus ≥1 weight-related comorbidity
  • No prior treatment with glucacon-like peptide-1 receptor agonists

Exclusion criteria

  • Current use of glucacon-like peptide-1 receptor agonists or dipeptidyl peptidase 4 inhibitors or use within the last 90 days prior to screening
  • Current antiobesity medication use or use within the last 90 days prior to screening
  • A self-reported change in body weight of >5 kg within 30 days before screening
  • History of bariatric surgery
  • History of diabetes mellitus
  • Hospitalization for unstable angina, or transient ischemic attack <30 days prior to screening
  • Pulmonary embolism <90 days before screening
  • Myocardial infarction, or stroke <90 days prior to screening
  • Uncontrolled thyroid disease: thyroid-stimulating hormone >10.0 mIU/L or <0.4 mIU/L at screening
  • Active malignancy
  • Acute pancreatitis <180 days before screening
  • History or presence of chronic pancreatitis
  • Chronic kidney disease with creatinine clearance <30 mL/min
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • Chronic inflammatory conditions requiring immunosuppression and/or on glucocorticoids
  • Pregnancy, breast-feeding or planning pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07389941 · SPICE_AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗