Recruiting

Atrial Fibrillation Ablation

Sponsor:

Atrial Fibrillation Network

Code:

NCT06324188

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early atrial fibrillation ablation

Usual Care

Study Details

Brief summary:

EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).

The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.

Conditions

Atrial Fibrillation

Study ID

NCT06324188

Start date

Oct 14, 2024

Status verified date

Nov, 2025

Completion date

May, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2312 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Early atrial fibrillation ablation

other: Usual Care

Interventions

Early atrial fibrillation ablation

Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.

Usual Care

Usual care will consist of optimal AF therapy based on guideline recommendations and local protocols and usage.The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.

Primary outcome measure

  • Composite of cardiovascular complications related to AF [ Time Frame: Throughout study completion, estimated at a mean of 4 years ]
  • The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. [ Time Frame: Throughout study completion, estimated at a mean of 4 years ]

Central Contacts and Locations

Central contacts

Antje Albring, Dr.

+49 251 980 1330easthigh@af-net.eu

Anna-Katharina Quade

+49 251 980 1330easthigh@af-net.eu

Locations

Several sites

Recruiting

Multiple Locations, Canada

More Information

Sponsor

Atrial Fibrillation Network

Last update posted

Jan 8, 2026

Last verified

Nov, 2025

Keywords

  • Early atrial fibrillation ablation
  • High comorbidity burden
  • CHA2DS2-VASc score
  • Early rhythm control
  • Stroke
  • Heart failure
  • Cardiovascular death
  • Cryoballoon

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atrial Fibrillation Network on 2026-01-08.