Personalized AF ablation guided by non-invasive global mapping

Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping - the CURE-AF Pilot Study

This project will test whether using a non-invasive global mapping system to guide personalized additional ablation after standard pulmonary vein isolation helps people with persistent atrial fibrillation and enlarged left atria have fewer recurrences.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: German Heart Institute (other)
• Locations: 5 sites (Berlin and 4 other locations)
• Trial ID: NCT07320560 on ClinicalTrials.gov

What this trial studies

This pilot interventional study enrolls ablation‑naïve patients with persistent atrial fibrillation and left atrial enlargement who are scheduled for catheter ablation. All participants undergo standard empirical pulmonary vein isolation followed by personalized targeting of up to three additional atrial regions identified by the temporal Stability of local Atrial High‑Rate Activity (SAHRA) using a non‑invasive global mapping system (Acorys). Selected regions with stable high‑rate activity are isolated or homogenized according to a predefined 15‑segment bi‑atrial model, with conventional intracardiac mapping used to guide ablation delivery. Participants are followed at 3, 6, and 12 months to record acute termination rates, arrhythmia recurrence, and safety signals.

Who should consider this trial

Good fit: Ideal candidates are ablation‑naïve adults with persistent atrial fibrillation who have evidence of left atrial enlargement and are suitable for catheter ablation.

Not a fit: Patients with prior cardiac ablation, significant left ventricular dysfunction (LVEF <35%), severe renal failure, prior stroke/TIA, or skin conditions that preclude non‑invasive mapping are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could reduce AF recurrence by identifying and targeting patient‑specific arrhythmia sources beyond standard pulmonary vein isolation.

How similar studies have performed: Previous small studies using electrocardiographic imaging and targeted ablation have shown mixed but promising signals, making this personalized non‑invasive mapping approach novel yet grounded in preliminary data.

Eligibility criteria

Inclusion Criteria:

Ablation-naïve patients with:

1. Persistent AF planned for catheter ablation plus
2. Left atrial enlargement (LA diameter ≥45 mm or LA volume index ≥35ml/m2 or LA area ≥20 cm2)

Exclusion Criteria:

* Previous cardiac ablation
* Age \<18 years
* Pregnancy or lactation
* Previous stroke/TIA
* Severe left ventricular dysfunction (LVEF \<35%)
* Renal failure (GFR \<30 ml/min)
* Dermal disease or hypersensitivity predisposing for skin irritation or exanthema

Where this trial is running

Berlin and 4 other locations

• German Heart Center of the Charité, Charité University Hospital Berlin — Berlin, Germany (RECRUITING)
• Frankfurt University Heart and Vascular Center — Frankfurt am Main, Germany (NOT_YET_RECRUITING)
• Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta — Lisbon, Portugal (NOT_YET_RECRUITING)
• Hospital Clinic, University of Barcelona — Barcelona, Spain (NOT_YET_RECRUITING)
• Gregorio Marañón General University Hospital — Madrid, Spain (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Till F Althoff, M.D. — German Heart Center of the Charitè, Berlin, Department of Cardiology, Angiology and Intensive Care Medicine
• Study coordinator: Till F Althoff, M.D.

Conditions: Atrial Fibrillation, Catheter Ablation, Non-invasive mapping, Global Mapping, Electrocardiographic Imaging, Body Surface Mapping, Atrial fibrillation drivers