Early Atrial Fibrillation Ablation for Stroke Prevention in Patients with High Comorbidity Burden (EASThigh-AFNET 11)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• I1. AF first diagnosed within 2 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 from Medtronic
• I4. Age ≥ 18 years
• I5. Provision of signed informed consent
Locations
Other Locations
Australia
Several sites
NOT_YET_RECRUITING
Multiple Locations
Canada
Several sites
NOT_YET_RECRUITING
Multiple Locations
Germany
Several sites
RECRUITING
Multiple Locations
Netherlands
Several sites
NOT_YET_RECRUITING
Multiple Locations
United Kingdom
Several sites
NOT_YET_RECRUITING
Multiple Locations
Contact Information
Primary
Antje Albring, Dr.
easthigh@af-net.eu
+49 251 980 1330
Backup
Anna-Katharina Quade
easthigh@af-net.eu
+49 251 980 1330
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2030-05
Participants
Target number of participants: 2312
Treatments
Other: Early atrial fibrillation ablation
Other: Usual Care
Related Therapeutic Areas
Sponsors
Leads: Atrial Fibrillation Network