Waiting on Atrial fibrillation Intervention Therapy (WAIT) Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-12-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of this trial is to evaluate whether treatment with a GLP-1 receptor agonist (semaglutide) in overweight or obese patients scheduled for first-time catheter ablation for atrial fibrillation can improve arrhythmia-free survival at 12 months post-ablation compared to standard of care.

Conditions and MedDRA coding

Atrial fibrillation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Provision of written informed consent prior to participation.
2. Age ≥18 years
3. Scheduled for first-time catheter ablation for atrial fibrillation using a pulmonary vein isolation (PVI) technique.
4. 4. Body Mass Index (BMI) ≥30 kg/m² (obesity) OR BMI ≥27 kg/m² (overweight) with one or more of the comorbidities listed in the protocol under section 6.1, inclusion criteria nr. 4.
5. 5. For women of childbearing potential: Inclusion after a highly sensitive negative pregnancy test and agreement to use highly effective contraception during the study period (e.g., hormonal contraception, intrauterine device, or barrier method combined with spermicide).

Exclusion criteria 15

1. Morbid obesity (BMI >40 kg/m²).
2. Life expectancy <12 months.
3. Inability to self-administer the investigational medicinal product.
4. Prior catheter ablation procedure for atrial fibrillation.
5. Pregnancy, breastfeeding, or planned pregnancy during or within two months after the study period.
6. Participation in another interventional clinical trial within the past 30 days.
7. Current use of GLP-1 receptor agonist therapy or dual agonist therapy within 6 months before screening.
8. Current use of DPP-IV inhibitors
9. Known intolerance or contraindication to semaglutide.
10. History of pancreatitis or recurrent hypoglycemia.
11. Uncontrolled diabetic retinopathy
12. Severe renal failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m² or in dialysis)
13. Severe hepatic failure (decompensated liver disease Child–Pugh class C)
14. Severe cardiac failure (NYHA class IV)
15. Diabetes type 1

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary variable: Freedom from atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds as detected by continuous monitoring via implantable loop recorder at 12 months post-ablation. Events within the initial 3-month blanking period will not be included.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation

Karolinska University Hospital

Address

Halsovagen, Flemingsberg Flemingsberg

City

Huddinge

Postcode

141 86

Country

Sweden

Scientific contact point

Organisation

Karolinska University Hospital

Contact name

Emma Svennberg

Public contact point

Organisation

Karolinska University Hospital

Contact name

Emma Svennberg

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications