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OpenTrials
Active, Not Recruiting

NCT Number: NCT06803615

Noninvasive Mapping Before Surgical Ablation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Electrocardiographic imaging

Device

Electrocardiographic imaging is an electrophysiological mapping technique which is used to noninvasively map cardiac arrhythmias.

Other names: Noninvasive surface mapping, Noninvasive mapping, Beat-to-beat noninvasive 3D mapping

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: NIMSA

Important dates

Study start
2017
Primary completion
2024
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Jun 29, 2025

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.

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