Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping

Official title

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

Overview

This pilot study investigates if non-invasive global mapping can guide catheter ablation of atrial fibrillation (AF) by defining personalized targets based on the temporal Stability of local Atrial High-Rate Activity (SAHRA). The study also assesses efficacy and safety of this approach and evaluates potential signals of harm. The main questions it aims to answer are: * Does ablation of targets defined by non-invasive 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 non-invasive 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

Detailed description

The aim of this study is to test the feasibility and potential of a personalized, non-invasive mapping-guided ablation approach in patients with persistent atrial fibrillation (AF), who are unlikely to benefit from empirical pulmonary vein isolation alone. As a pilot study, it is designed to assess feasibility and procedural efficacy as well as potential signals of harm.

General Strategy:

Patients with persistent AF planned for catheter ablation are eligible in case of left atrial enlargement.

The study intervention consists of two steps:

1. Empirical pulmonary vein isolation in all patients (current standard of care). 2. A personalized ablation approach targeting up to three additional atrial regions which harbour critical AF-perpetuating sources:

* Target regions are selected based on the temporal Stability of local Atrial High-Rate Activity (SAHRA) using a non-invasive global mapping system (Acorys, Corify Care). * Selected target regions displaying stable high-rate activity are isolated or homogenized according to predefined regional borders based on the 15-segment bi-atrial model of the EHRA and EACVI Clinical Consensus on Standardized Atrial Regionalization.

Interventions

• Procedure Non-invasive mapping-guided ablation
  The study intervention consists of 1. Empirical pulmonary vein isolation (current standard of care) plus 2. A personalized ablation approach targeting up to three additional atrial regions which harbour critical AF-perpetuating sources: * Target regions are selected based on the temporal Stability of local Atrial High-Rate Activity (SAHRA) using a non-invasive global mapping system (Acorys, Corify Care). Local high-rate activity is confirmed by endocardial mapping. * Selected target regi

Primary outcome measures

• Rate of acute AF termination [Time frame: Procedural]

Secondary outcome measures (5)

• Proportion of patients with arrhythmia-free survival [Time frame: Days 91 to 365 post-ablation]
• Proportion of patients with AF-free survival [Time frame: Days 91 to 365 post-ablation]
• Time to arrhythmia recurrence [Time frame: Days 91 to 365 post-ablation]
• Time to AF recurrence [Time frame: Days 91 to 365 post-ablation]
• Rate of procedure-related complications [Time frame: Day 0 to 30 post-ablation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 2 centers

• German Heart Center of the Charité, Charité University Hospital Berlin — Berlin
• Frankfurt University Heart and Vascular Center — Frankfurt am Main

Spain · 2 centers

• Hospital Clinic, University of Barcelona — Barcelona
• Gregorio Marañón General University Hospital — Madrid

Portugal · 1 center

• Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta — Lisbon

Publications

• Invers-Rubio E, Hernandez-Romero I, Reventos-Presmanes J, Ferro E, Guichard JB, Regany-Closa M, Pellicer-Sendra B, Borras R, Prat-Gonzalez S, Tolosana JM, Porta-Sanchez A, Arbelo E, Guasch E, Sitges M, Brugada J, Guillem MS, Roca-Luque I, Climent AM, Mont L, Althoff TF. Regional conduction velocities determined by noninvasive mapping are associated with arrhythmia-free survival after atrial fibril PMID 38636930
• Althoff TF, Anderson RH, Goetz C, Petersen SE, Diaz PM, Nijveldt R, Maurovich-Horvat P, Bax J, Hussain S, Schmidt C, Spicer DE, Sanchez-Quintana D, Corsi C, Dossel O, Climent AM, Rodriguez B, Schotten U, Loewe A, Guillem MS, Cabrera JA, Merino JL, Wijnmaalen AP, Bertrand PB, de Groot N, Derval N, Didenko M, Donal E, Dweck MR, Ho SY. Regionalization of the atria for 3D electroanatomical mapping, ca PMID 40736086

Identifiers

NCT: NCT07320560 · EA1/204/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗