Early atrial fibrillation ablation for stroke prevention in patients with high comorbidity burden

The investigator-initiated EASThigh-AFNET 11 trial evaluates the effectiveness and safety of early AF ablation compared to usual care in patients with recently diagnosed AF and a high comorbidity burden. EASThigh-AFNET 11 is a prospective, randomized, open, blinded endpoint assessment, multicenter trial, randomizing 2312 patients with AF and a high comorbidity burden to early AF ablation or usual care. All therapies are clinically approved. The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for worsening of heart failure. Secondary outcome parameters address safety, health-economic outcomes, patient reported outcomes, and cognitive function. EASThigh-AFNET 11 will provide guideline-changing information on the effectiveness and safety of ablation-based rhythm control therapy in a large at-risk population of patients with AF.

Based on the successful experience of the EAST-AFNET 4 trial different types of study sites will create local study clusters consisting of one ablation site (A-site) and additional surrounding, non-ablating study sites (S-sites) consisting of hospitals or office-based cardiologists. Participating ablation sites should have sufficient experience with AF ablation to deliver safe AF ablation procedures to patients with multiple comorbidities including repeat procedures.

All study sites will be contracted and are able to screen, randomize, and follow study patients. In case a patient is randomized to the early AF ablation group at an S-site, AF ablation will be performed at the corresponding A-site of the particular study cluster. However, the patient remains a study patient of his enrolling S-site and will be followed there.

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.

AF first diagnosed within 2 years prior to enrolment and documented in body surface ECG, high comorbidity estimated by CHA2DS2-VASc score of 4 or more, patient suitable for ablation using cryoballoon ablation systems from Medtronic, age ≥ 18 years, provision of signed informed consent.

General exclusion criteria: Any disease that limits life expectancy to less than 1 year, participation in another clinical trial, either within the 3 months prior to enrolment or still on-going, previous participation in EASThigh-AFNET 11, pregnant women, breastfeeding women, drug abuse or clinically manifest alcohol abuse. Exclusion criteria related to a cardiac condition: Prior AF ablation or surgical therapy of AF, patients not suitable for AF ablation, patients with a history of stroke which occurred within 3 months prior to enrolment, valve disease requiring specific therapy. Exclusion criteria based on laboratory abnormalities: Clinically manifested thyroid dysfunction requiring therapy.

EASThigh-AFNET 11 compares two different treatment strategies established in routine clinical care. None of the medical therapies or procedures employed in EASThigh-AFNET 11 is investigational. The only intervention in this trial is the randomisation to one of the two dedicated treatment strategies, consisting of different treatment approaches both using approved, marketed and recommended therapies for the type of AF in focus.

Studiendesign

prospektiv, randomisiert, kontrolliert

Angestrebte Patientenzahl (bereits eingeschlossen)

2312

Dauer Follow Up

median follow-up time of about 44 months

Status

aktiv

Ethikvotum

Lokal vorliegend

Antizipierter Studienzeitraum

2024 - 2030

Geplante Anzahl teilnehmender Zentren

200

Davon bereits aktiv

12

Funding für teilnehmende Zentren

Ja