Early atrial fibrillation ablation for patients with high comorbidity burden
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
This study is testing if early heart procedure called ablation can help people with atrial fibrillation and other health issues avoid serious problems like strokes and heart failure better than regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2312 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Atrial Fibrillation Network Academic / other |
| Locations | 7 sites (Multiple Locations and 6 other locations) |
| Trial ID | NCT06324188 on ClinicalTrials.gov |
What this trial studies
EASThigh-AFNET 11 is an international, multicenter trial that investigates the effectiveness of early atrial fibrillation ablation in patients with a high comorbidity burden, specifically those with a CHA2DS2-VASc score of 4 or more. The trial aims to determine if this intervention can reduce cardiovascular events such as stroke, cardiovascular death, and heart failure compared to usual care. By randomizing 2312 patients, the study will assess the safety and efficacy of ablation versus standard treatment approaches. The focus is on patients recently diagnosed with atrial fibrillation who are suitable for cryoballoon ablation systems.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed atrial fibrillation and a CHA2DS2-VASc score of 4 or higher.
Not a fit: Patients with a life expectancy of less than one year or those unsuitable for atrial fibrillation ablation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of serious cardiovascular events in patients with atrial fibrillation and multiple comorbidities.
How similar studies have performed: Previous studies have indicated that early rhythm control can reduce complications in atrial fibrillation, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Multiple Locations and 6 other locations
- Several sites — Multiple Locations, Australia (Not_yet_recruiting)
- Several sites — Multiple Locations, Canada (Recruiting)
- Several sites — Multiple Locations, Germany (Recruiting)
- Several sites — Multiple Locations, Netherlands (Recruiting)
- Several sites — Multiple Locations, Poland (Recruiting)
- Several sites — Multiple Locations, Spain (Recruiting)
- Several sites — Multiple Locations, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Jason Andrade, Prof. Dr. — University of British Columbia, Vancouver General Hospital, Department of Electrophysiology
- Study coordinator: Antje Albring, Dr.
- Email: easthigh@af-net.eu
- Phone: +49 251 980 1330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.