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

February 8, 2026 updated by: Roland Richard Tilz, MD, University of Luebeck

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Catheter ablation for atrial fibrillation plus semaglutide
Catheter ablation for atrial fibrillation plus semaglutide (up to 2.4 mg weekly)
Drug: Semaglutide (SEMA)
Catheter ablation for AF plus semaglutide (up to 2.4 mg weekly)
No Intervention: Catheter ablation for atrial fibrillation and no glucacon-like peptide-1 receptor therapy
Catheter ablation for atrial fibrillation and no glucacon-like peptide-1 receptor therapy (standard therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPICE_AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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