Non-invasive Mapping-Guided Atrial Fibrillation Ablation
Recruiting · NCT07358611 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Clinic of Barcelona
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this pilot study is to test if noninvasive global mapping can guide catheter ablation defining personalized targets and improve the therapy of atrial fibrillation. It will also test the safety of such an approach. The main questions it aims to answer are: * Does ablation of targets defined by noninvasive global mapping improve rates of acute atrial fibrillation termination? * Does such a personalized ablation approach reduce arrhythmia recurrence rates? Researchers will compare the results of the personalized ablation approach with comparable patients that had undergone a conventional "empirical" ablation approach (pulmonary vein isolation). Participants will: * Undergo a personalized catheter ablation approach employing both a noninvasive global mapping system and a conventional intracardiac mapping system * Visit the clinic 3, 6 and 12 months after ablation for clinical follow-up * Schedule a telephone visit 9 and 24 months after ablation for clinical follow-up
Who can take part
Inclusion criteria
- Ablation-naïve patients with:
- Persistent AF planned for catheter ablation plus
- 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 it is running
1 location listed.
- Hospital Clinic, University of Barcelona - Barcelona, Spain