Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping (CURE-AF)

December 25, 2025 updated by: Till Althoff, German Heart Institute

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10117
      • Frankfurt am Main, Germany, 60598
  • Portugal
      • Lisbon, Portugal, 1169-024
        • Not yet recruiting
        • Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta
        • Contact:
        • Principal Investigator:
          • Mario Martins Oliveira, M.D.
  • Spain
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Hospital Clinic, University of Barcelona
        • Contact:
          • Ivo Roca-Luque, M.D. Ph.D.
          • Phone Number: 0034 93 2271778
          • Email: iroca@clinic.cat
        • Principal Investigator:
          • Ivo Roca-Luque, M.D.
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Gregorio Marañón General University Hospital
        • Contact:
        • Principal Investigator:
          • Felipe Atienza, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-invasive mapping-guided ablation
In this arm patients undergo a personalized ablation approach: In addition to conventional pulmonary vein isolation, additional target regions will be ablated based on non-invasive global mapping.
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 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 (Althoff et al. 2025).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of acute AF termination
Time Frame: Procedural
Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation
Procedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with arrhythmia-free survival
Time Frame: Days 91 to 365 post-ablation
Absence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.
Days 91 to 365 post-ablation
Proportion of patients with AF-free survival
Time Frame: Days 91 to 365 post-ablation
Absence of atrial fibrillation [AF] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer.
Days 91 to 365 post-ablation
Time to arrhythmia recurrence
Time Frame: Days 91 to 365 post-ablation
Time to first atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.
Days 91 to 365 post-ablation
Time to AF recurrence
Time Frame: Days 91 to 365 post-ablation
Time to first atrial fibrillation [AF] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer.
Days 91 to 365 post-ablation
Rate of procedure-related complications
Time Frame: Day 0 to 30 post-ablation

Composite safety endpoint composed of:

  • cardiac tamponade requiring drainage
  • persistent phrenic nerve palsy lasting >24 hours
  • serious vascular complications requiring intervention
  • stroke/TIA
  • atrioesophageal fistula
  • death
Day 0 to 30 post-ablation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total left atrium indwelling time
Time Frame: Day 0
Procedural endpoint
Day 0
Procedure time
Time Frame: Day 0
Skin-to-skin duration of the ablation (procedural endpoint)
Day 0
Fluoroscopy time
Time Frame: Day 0
Procedural endpoint
Day 0
Hemolysis marker levels on day 1 post-ablation
Time Frame: Day 1 post-ablation
Procedural endpoint
Day 1 post-ablation
GFR on day 1 post-ablation
Time Frame: Day 1 post-ablation
Procedural endpoint
Day 1 post-ablation
Proportion of patients with acute renal failure
Time Frame: Day 0 to 30 post-ablation
Procedural endpoint
Day 0 to 30 post-ablation
hsTroponin on day 1 post-ablation
Time Frame: Day 1 post-ablation
Procedural endpoint
Day 1 post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Heart Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/204/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data underlying published results will be provided upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation (AF)

Clinical Trials on Non-invasive mapping-guided ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe