Atrial Fibrillation (AF)NIMSANCT06803615
Noninvasive Mapping Before Surgical Ablation
An observational study of Atrial Fibrillation (AF), run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Electrocardiographic imaging
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteAustria
- Study dates
- 13 Jan 2017to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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)
- Being tested
- Electrocardiographic imaging
- Keywords
- Atrial Fibrillation, Electrocardiographic Imaging, Noninvasive Mapping, Surgical Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiographic imagingDevice
Also called Noninvasive surface mapping, Noninvasive mapping, Beat-to-beat noninvasive 3D mapping
Electrocardiographic imaging is an electrophysiological mapping technique which is used to noninvasively map cardiac arrhythmias.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to the planned procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start13 Jan 2017
- Primary completion1 Jan 2024
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio Osorio, MD, Medical University of Vienna
- Investigators
- Emilio Osorio, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803615
- Sponsor's protocol ID
- 1046/2018
- Acronym
- NIMSA
- Status last verified
- Jun 2025
- First submitted
- 27 Jan 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be shared on reasonable request to the principal investigator.
Publications
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.
PubMed 40828886
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06803615
- Acronym / sponsor ID
- NIMSA / 1046/2018
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, Electrocardiographic Imaging, Noninvasive Mapping, Surgical Ablation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiographic imagingAlso: Noninvasive surface mapping, Noninvasive mapping, Beat-to-beat noninvasive 3D mappingElectrocardiographic imaging is an electrophysiological mapping technique which is used to noninvasively map cardiac arrhythmias. | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Derived from this study: PubMed 40828886Osorio-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.
- Individual participant dataSharing planned: Yes. IPD will be shared on reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Osorio, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06803615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.