Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:16 PM
Study NCT ID:
NCT07320560
Status:
RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping
Sponsor:
German Heart Institute
Organization:
Study Overview
Official Title:
Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping - the CURE-AF Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CURE-AF
Brief Summary:
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
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: