Noninvasive Mapping Before Surgical Ablation (NIMSA)

June 25, 2025 updated by: Emilio Osorio, MD, Medical University of Vienna

The Use of Beat-to-Beat Noninvasive 3D Mapping to Study Patients Candidates for Concomitant Surgical Ablation for Persistent and Long-standing Persistent Atrial Fibrillation

The purpose of this study is to assess the electrophysiological mechanism of atrial fibrillation by means of a beat-to-beat noninvasive 3D mapping method in patients with concomitant persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

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

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

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

Sampling Method

Non-Probability Sample

Study Population

Patients with persistent or long-standing persistent atrial fibrillation scheduled for concomitant surgical ablation at Vienna General Hospital of the Medical University of Vienna.

Description

Inclusion Criteria:

  • legal age (18-90a)
  • life expectancy > 2 years
  • patients suffering from persistent and long standing atrial fibrillation
  • scheduled for concomitant surgical ablation
  • possibility to follow-up
  • given informed consent

Exclusion Criteria:

  • vulnerable patient groups
  • pregnancy
  • any previous surgical ablation
  • acute surgical indications
  • any physical condition that leads to a life expectancy of less than two years

  • any contraindication to the treatments necessary for the trial's conduction as e.g.

    • known allergic reaction to contrast agent
    • known allergic reaction to antiarrhythmic drugs
    • claustrophobia or anxiety in small spaces
    • severe renal impairment
    • unmanageable hyperthyroidism
  • participation in any other clinical trial that either excludes enrolment or may be a confounding factor to results
  • voluntary retention

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The patients electrophysiological mapping results acquired with ECGI will be analyzed: Number and distribution of rotor and focal activities will be measured.
Time Frame: Prior to the planned procedure.
The primary objective of this study is to measure the patients electrophysiological mapping results acquired with ECGI, namely the number and distribution of focal and rotor activities.
Prior to the planned procedure.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from AF during 12 and 24 months of follow-up.
Time Frame: From surgery until 24 months after the procedure.
A pre-specified outcome measure is to measure freedom from AF during 12 and 24 months of follow-up. The impact of the preoperative mapping results and the applied respective ablation technique will be analyzed.
From surgery until 24 months after the procedure.

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Emilio Osorio, MD, Medical University of Vienna

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 (Actual)

January 13, 2017

Primary Completion (Actual)

January 1, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1046/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared on reasonable request to the principal investigator.

IPD Sharing Time Frame

From 03/2025 until 12/2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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