Atrial FibrillationNCT05539313
Examination of Fibrillation Atria Using Magnetic Resonance Imaging and Endocardial High-density Mapping
An observational study of Atrial Fibrillation, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Cather ablation of non-paroxysmal atrial fibrillation is less effective compared to paroxysmal atrial fibrillation. Therefore, new techniques have been developed, such as high-density mapping to determine areas of focal and rotational activities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- High-density mapping
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Adult, Older adult
Study population: Patients with non - paroxysmal, i.e. persistent or long-lasting persistent symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation
Who may be able to join
- non-paroxysmal atrial fibrillation
Who cannot join
- creatinine > 120 umol/l
- claustrofobia
- pregnancy
- mechanical valve
- significant valve disease
- left ventricular dysfunction, EF less than 35%
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, 10034
Pavel Osmancik, MD, PhD, 00420 ext. 721544447, pavel.osmancik@volny.cz
About this study
Official title: The Investigation and Analysis of Atria of Patients With Non-paroxysmal Atrial Fibrillation Using High-desnity Mapping and Cardiac Magnetic Resonance Imaging
Cather ablation of non-paroxysmal atrial fibrillation is less effective compared to paroxysmal atrial fibrillation. Therefore, new techniques have been developed, such as high-density mapping to determine areas of focal and rotational activities. The aim is to assess the clinical efficacy of ablation focal and rotational activities, and to assess the relation between the areas of focal and rotational activities with fibrosis of both atria assessed using magnetic resonance.
Read the detailed description
Pateints with non-paroxysmal atrial fibrillation will be enrolled. Before the procedure, cardiac magnetic resonance will be done to determine the extent and location of atrial fibrosis of both atria using dedicated software. The procedure itself will be done standardly, in alangosedation, from both femoral veins, using 10-pole catheter in the coronary sinus, intracardiac echocardiography, and two transseptal punctures by means of SL1 sheaths. Octarey mapping catheter (Biosense Webster, USA) wil be inserted in the left atrium, and during ongoing atrial fibrillation, a maping of left atrium will be done to locate the areas of focal and rotational activities. Afterthat, using Smart Touch ablation catheter (Biosense Webster, USA), pulmonary vein isolation will be done. When PVI is achieved, all areas of focal and rotational activities determined by high-density mapping will be performed. If sinus rhythm is achieved, the procedure is finished. If atrial fibrilaltion is organized to regular atrial, this regular tachacardia is mapped, ablated and the procedure is finished. If atrial fibrilaltion continues, mapping of the righ atrium using the same technique is done followed by catheter ablation of areas of focal and rotational activities. If atrial fibrillation is still present after all these ablation, electrical cardioversion will be done.
Patients will be discharged on following day. 5-day Holter recording will be done in 3, 6, and 12 months during standard out-patient controls.
The aim is to compare the findings of high-density mapping with findings on atrial MRI (relation between fibrosis on MRI and locations of rotational and focal activities). Furher aim is to assess the efficaccy of this kidn of ablation, i.e. the sinus rhythm maintenance in 3,6, and 12 months.
- Conditions
- Atrial Fibrillation
- Being tested
- High-density mapping
- Keywords
- atrial fibrillation, catheter ablation, cardiac magnetic resonance, high-density mapping
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-density mappingDevice
Patients will undergo magnetic resonance imaging of both atria, and interventional high-density mapping of both atria.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus rhythm maintenance
The freedom from atrial fibrillation
Measured: 1 year
MRI and high-density relation
The relation between areas of location and rotational activities with atrial fibrosis location
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Nov 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavel Osmancik, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539313
- Sponsor's protocol ID
- MRI Octarey
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol will shared after study initiation
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation and Analysis of Atria of Patients With Non-paroxysmal Atrial Fibrillation Using High-desnity Mapping and Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05539313
- Acronym / sponsor ID
- MRI Octarey
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, cardiac magnetic resonance, high-density mapping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Sep 2022 (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.
Cather ablation of non-paroxysmal atrial fibrillation is less effective compared to paroxysmal atrial fibrillation. Therefore, new techniques have been developed, such as high-density mapping to determine areas of focal and rotational activities. The aim is to assess the clinical efficacy of ablation focal and rotational activities, and to assess the relation between the areas of focal and rotational activities with fibrosis of both atria assessed using magnetic resonance.
Detailed description
Pateints with non-paroxysmal atrial fibrillation will be enrolled. Before the procedure, cardiac magnetic resonance will be done to determine the extent and location of atrial fibrosis of both atria using dedicated software. The procedure itself will be done standardly, in alangosedation, from both femoral veins, using 10-pole catheter in the coronary sinus, intracardiac echocardiography, and two transseptal punctures by means of SL1 sheaths. Octarey mapping catheter (Biosense Webster, USA) wil be inserted in the left atrium, and during ongoing atrial fibrillation, a maping of left atrium will be done to locate the areas of focal and rotational activities. Afterthat, using Smart Touch ablation catheter (Biosense Webster, USA), pulmonary vein isolation will be done. When PVI is achieved, all areas of focal and rotational activities determined by high-density mapping will be performed. If sinus rhythm is achieved, the procedure is finished. If atrial fibrilaltion is organized to regular atrial, this regular tachacardia is mapped, ablated and the procedure is finished. If atrial fibrilaltion continues, mapping of the righ atrium using the same technique is done followed by catheter ablation of areas of focal and rotational activities. If atrial fibrillation is still present after all these ablation, electrical cardioversion will be done.
Patients will be discharged on following day. 5-day Holter recording will be done in 3, 6, and 12 months during standard out-patient controls.
The aim is to compare the findings of high-density mapping with findings on atrial MRI (relation between fibrosis on MRI and locations of rotational and focal activities). Furher aim is to assess the efficaccy of this kidn of ablation, i.e. the sinus rhythm maintenance in 3,6, and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with non - paroxysmal, i.e. persistent or long-lasting persistent symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation
Key inclusion criteria (1 listed)
- non-paroxysmal atrial fibrillation
Key exclusion criteria (6 listed)
- creatinine > 120 umol/l
- claustrofobia
- pregnancy
- mechanical valve
- significant valve disease
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 |
|---|---|---|
| High-density mappingPatients will undergo magnetic resonance imaging of both atria, and interventional high-density mapping of both atria. | Device | – |
Primary outcome
Sinus rhythm maintenance
Time frame: 1 year
The freedom from atrial fibrillation
MRI and high-density relation
Time frame: 3 days
The relation between areas of location and rotational activities with atrial fibrosis location
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Yes. Protocol will shared after study initiation
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
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, run by Charles University, Czech Republic at 1 site in Czechia.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel Osmancik (+420721544447, pavel.osmancik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinus rhythm maintenance (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.