Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation

NCT07389941 | Not Yet Recruiting Phase 4

• 1 other identifier: SPICE_AF
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (2)

Catheter ablation for atrial fibrillation plus semaglutide

EXPERIMENTAL

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

Drug: Semaglutide (SEMA)

Catheter ablation for atrial fibrillation and no glucacon-like peptide-1 receptor therapy

NO INTERVENTION

Catheter ablation for atrial fibrillation and no glucacon-like peptide-1 receptor therapy (standard therapy)

Interventions

Semaglutide (SEMA) DRUG

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

Catheter ablation for atrial fibrillation plus semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Luebeck: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Rhythmology

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share