Study
Recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Several sites | Multiple Locations | Australia | Not yet recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
I1. AF first diagnosed within 5 years prior to enrolment and documented in body surface ECG
I2. High comorbidity estimated by CHA2DS2-VASc score of 4 or more
I3. Patient suitable for ablation using cryoballoon ablation systems or other ablation systems with comparable efficacy and safety from Medtronic
I4. Age ≥ 18 years
I5. Provision of signed informed consent
Exclusion Criteria:
General exclusion criteria
E1. Any disease that limits life expectancy to less than 1 year.
E2. Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in potential sub-studies connected to this trial is permitted).
E3. Previous participation in EASThigh-AFNET 11.
E4. Pregnant women.
E5. Breastfeeding women.
E6. Drug abuse or clinically manifest alcohol abuse.
Exclusion criteria related to a cardiac condition
E7. Prior AF ablation or surgical therapy of AF.
E8. Patients not suitable for AF ablation.
E9. Patients with a history of stroke which occurred within 3 months prior to enrolment.
E10. Valve disease requiring specific therapy.
Exclusion criteria based on laboratory abnormalities
E11. Clinically manifested thyroid dysfunction requiring therapy.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 8 January 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.