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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
German Heart Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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