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NCT Number: NCT07389941

Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semaglutide (SEMA)

Drug

Catheter ablation for AF plus semaglutide (up to 2.4 mg weekly)

Primary outcomes

  1. Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study title

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

Acronym: SPICE-AF

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 5, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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