Noninvasive Mapping Before Surgical Ablation

NCT06803615 | Active Not Recruiting FDA Device

• 1 other identifier: 1046/2018
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Electrocardiographic Imaging; Noninvasive Mapping; Surgical Ablation

Outcome Measures

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.

  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 Outcomes (1)

• Freedom from AF during 12 and 24 months of follow-up.

  From surgery until 24 months after the procedure.

Interventions

Electrocardiographic imaging DEVICE

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

Also known as: Noninvasive surface mapping, Noninvasive mapping, Beat-to-beat noninvasive 3D mapping

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Osorio-Jaramillo E, Conci L, Schloglhofer T, Coti I, Strassl A, Schukro C, Zimpfer D, Ehrlich MP, Ad N. Electrocardiographic Imaging as Preoperative Tool in Persistent and Long-Standing Persistent Atrial Fibrillation: A Prospective Observational Study. Interdiscip Cardiovasc Thorac Surg. 2025 Sep 1;40(9):ivaf198. doi: 10.1093/icvts/ivaf198.

  PMID: 40828886 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emilio Osorio, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: January 13, 2017
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 03/2025 until 12/2025

Locations

AU (1)