Using noninvasive mapping to guide atrial fibrillation ablation
ELectrocardiographic Imaging-guided Substrate Ablation in Patients With Atrial Fibrillation - a PILOT Study of a Personalized Therapy
This will test whether using noninvasive heart mapping to choose personalized ablation targets helps people with persistent atrial fibrillation and enlarged left atria by increasing immediate AF termination and reducing later recurrences.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT07358611 on ClinicalTrials.gov |
What this trial studies
This pilot uses a noninvasive global mapping system (Acorys, Corify Care) to identify up to three atrial regions with stable high-rate activity (SAHRA) in patients with persistent AF and left atrial enlargement. All participants receive standard pulmonary vein isolation plus targeted isolation or homogenization of selected regions guided by the noninvasive map and conventional intracardiac mapping. The study records procedural efficacy, acute AF termination rates, and safety signals, with in-person follow-up at 3, 6, and 12 months and telephone follow-up at 9 and 24 months. Results will be compared with comparable patients who underwent empirical pulmonary vein isolation to look for feasibility and preliminary efficacy signals.
Who should consider this trial
Good fit: Ablation-naïve adults with persistent atrial fibrillation who have left atrial enlargement and are planned for catheter ablation are eligible.
Not a fit: Patients without left atrial enlargement, those with prior cardiac ablation, prior stroke/TIA, severe left ventricular dysfunction, or significant renal failure are unlikely to benefit or are excluded from this approach.
Why it matters
Potential benefit: If successful, this personalized mapping-guided approach could increase immediate AF termination and reduce arrhythmia recurrence after ablation for patients with persistent AF and enlarged left atria.
How similar studies have performed: Other driver-guided or mapping-based ablation approaches have produced mixed but sometimes promising results in small series, so the method is evolving and not yet fully validated.
Eligibility criteria
Show full inclusion / exclusion 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
Barcelona
- Hospital Clinic, University of Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Till F Althoff, M.D. — German Heart Center of the Charite, Berlin
- Study coordinator: Till F Althoff, M.D.
- Email: till.althoff@dhzc-charite.de
- Phone: +49 30 450513143
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.