Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07320560

Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Heart Center of the Charité, Charité University Hospital Berlin, Berlin, Germany

Loading trial locations.

About this study

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:

  • Empirical pulmonary vein isolation in all patients (current standard of care).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive mapping-guided ablation

Procedure

The study intervention consists of

  • Empirical pulmonary vein isolation (current standard of care) plus
  • 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).

Primary outcomes

  1. Rate of acute AF termination

    Time frame: Procedural

    Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Other outcomes

  1. Procedure time

    Time frame: Day 0

    Skin-to-skin duration of the ablation (procedural endpoint)

  2. Total left atrium indwelling time

    Time frame: Day 0

    Procedural endpoint

  3. Fluoroscopy time

    Time frame: Day 0

    Procedural endpoint

  4. Hemolysis marker levels on day 1 post-ablation

    Time frame: Day 1 post-ablation

    Procedural endpoint

  5. GFR on day 1 post-ablation

    Time frame: Day 1 post-ablation

    Procedural endpoint

  6. Proportion of patients with acute renal failure

    Time frame: Day 0 to 30 post-ablation

    Procedural endpoint

  7. hsTroponin on day 1 post-ablation

    Time frame: Day 1 post-ablation

    Procedural endpoint

Study contacts

Contact information is provided by the study sponsor or research team.

Gerhard Hindricks, M.D.

CONTACT

[email protected]

030450613163

Till F Althoff, M.D.

CONTACT

[email protected]

0049 30 450613163

Sponsors and collaborators

Lead sponsor

German Heart Institute

Other

Registry information

Official study title

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

Acronym: CURE-AF

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.