Atrial FibrillationNCT06478342
Left Atrial Function After Pulsed Field Ablation of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Charles University, Czech Republic.
Trial summary
Introduction: Pulsed field ablation (PFA) has emerged in routine clinical practice as a new promising technology in catheter-based treatment of atrial fibrillation (AF). The ease of PFA technology enables more extensive ablation in shorter time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ablation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for AF ablation procedures
Who may be able to join
- Non-paroxysmal AF with an indication for catheter ablation
- Age above 18
- Signed informed consent
Who cannot join
- Contraindication to MRI
- BMI > 35 kg/m2
- Contraindication to amiodarone
- Left atrial size > 60 mm
- History of any LA ablation
- Significant valvular disease (mitral regurgitation ¾ or greater, moderate or severe aortic stenosis)
- Severe pulmonary hypertension
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Introduction: Pulsed field ablation (PFA) has emerged in routine clinical practice as a new promising technology in catheter-based treatment of atrial fibrillation (AF). The ease of PFA technology enables more extensive ablation in shorter time. On one hand, extensive ablation is advocated to decrease the AF recurrence in persistent patients, on the other hand it is an important predictor of developing left atrial stiff syndrome with a reported incidence rate of 3.7 - 8.2 % in persistent patients during the era of radiofrequency ablation.
Goals of the study: The main hypothesis is that the LA function (strain) will tend to decline after extensive PFA. It will be assessed using transthoracic echocardiography (TTE) and magnetic resonance (MRI).
Read more
Secondary endpoint analysis will include the evaluation of the distribution of late gadolinium enhancement (LGE) after ablation compared to baseline scans, evaluation of heart failure biomarkers after ablation, and description of the rate of AF recurrence.
Methods: This project is a prospective, nonrandomised, two-centre (University Hospital Kralovske Vinohrady and University Hospital Motol) observational study including 50 non-paroxysmal AF patients with indication for catheter ablation. Before the ablation, all patients will undergo LGE MRI and TTE (after cardioversion if AF present). The ablation procedure will be performed using pulsed field technology and will include pulmonary vein isolation, posterior wall ablation and mitral isthmus ablation. Patients will be followed for 6 months. 3 months after the ablation, LGE MRI will be performed. TTE examinations will be carried out on the day after the ablation, at 3 and at 6 months. Heart failure biomarkers (N-terminal proatrial natriuretic peptide, fibroblast growth factor 23, and galectin 3) levels will be analysed at baseline, and 3 and 6 months after the procedure. ECG Holter monitoring will be performed at 3- and 6-months visits.
- Conditions
- Atrial Fibrillation
- Being tested
- ablation
- Keywords
- atrial fibrillation, pulsed field ablation, left atrial strain
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablationProcedure or surgery
Pulsed field ablation, MRI and TEE examinations (LA strain)
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Non-paroxysmal AF patients Receives: Procedure: ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in LA function (strain) by MRI (baseline vs. 3m values)
LA strain (baseline vs. 3 months)
Measured: Baseline MRI to 3 months after procedure
Changes in LA function (strain) by TTE (baseline vs. 3m values)
LA strain (baseline vs. 3 months)
Measured: Procedure to 3 months
Secondary outcomes (4)
Changes in LA fibrosis distribution (LGE MRI) (baseline vs. 3 m values)
LGE evaluation (baseline vs. 3 months MRI)
Measured: Baseline MRI to 3 months after procedure
Changes in ANP, FGF 23, GAL 3 levels (baseline vs. 3 m values)
laboratory analysis
Measured: baseline vs. 3 m values
AF freedom
defined as an absence of AF/atrial tachycardia lasting > 30 s during follow-up including Holter monitoring
Measured: Procedure to 6 months visit
Changes in strain function on TTE over time
comparison of strain values obtained at all 4 time points
Measured: baseline TTE to 6 months control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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, Marek Hozman, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478342
- Sponsor's protocol ID
- PFA - strain
- Status last verified
- Sep 2024
- First submitted
- 22 Jun 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Function After Pulsed Field Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06478342
- Acronym / sponsor ID
- PFA - strain
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, pulsed field ablation, left atrial strain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Jun 2024 (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.
Introduction: Pulsed field ablation (PFA) has emerged in routine clinical practice as a new promising technology in catheter-based treatment of atrial fibrillation (AF). The ease of PFA technology enables more extensive ablation in shorter time. On one hand, extensive ablation is advocated to decrease the AF recurrence in persistent patients, on the other hand it is an important predictor of developing left atrial stiff syndrome with a reported incidence rate of 3.7 - 8.2 % in persistent patients during the era of radiofrequency ablation.
Goals of the study: The main hypothesis is that the LA function (strain) will tend to decline after extensive PFA. It will be assessed using transthoracic echocardiography (TTE) and magnetic resonance (MRI).
Secondary endpoint analysis will include the evaluation of the distribution of late gadolinium enhancement (LGE) after ablation compared to baseline scans, evaluation of heart failure biomarkers after ablation, and description of the rate of AF recurrence.
Methods: This project is a prospective, nonrandomised, two-centre (University Hospital Kralovske Vinohrady and University Hospital Motol) observational study including 50 non-paroxysmal AF patients with indication for catheter ablation. Before the ablation, all patients will undergo LGE MRI and TTE (after cardioversion if AF present). The ablation procedure will be performed using pulsed field technology and will include pulmonary vein isolation, posterior wall ablation and mitral isthmus ablation. Patients will be followed for 6 months. 3 months after the ablation, LGE MRI will be performed. TTE examinations will be carried out on the day after the ablation, at 3 and at 6 months. Heart failure biomarkers (N-terminal proatrial natriuretic peptide, fibroblast growth factor 23, and galectin 3) levels will be analysed at baseline, and 3 and 6 months after the procedure. ECG Holter monitoring will be performed at 3- and 6-months visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Procedure: ablationNon-paroxysmal AF patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for AF ablation procedures
Key inclusion criteria (3 listed)
- Non-paroxysmal AF with an indication for catheter ablation
- Age above 18
- Signed informed consent
Key exclusion criteria (8 listed)
- Contraindication to MRI
- BMI > 35 kg/m2
- Contraindication to amiodarone
- Left atrial size > 60 mm
- History of any LA ablation
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 |
|---|---|---|
| ablationPulsed field ablation, MRI and TEE examinations (LA strain) | Procedure or surgery | Prospective cohort |
Primary outcome
Changes in LA function (strain) by MRI (baseline vs. 3m values)
Time frame: Baseline MRI to 3 months after procedure
LA strain (baseline vs. 3 months)
Changes in LA function (strain) by TTE (baseline vs. 3m values)
Time frame: Procedure to 3 months
LA strain (baseline vs. 3 months)
4 secondary outcomes
Changes in LA fibrosis distribution (LGE MRI) (baseline vs. 3 m values)
Time frame: Baseline MRI to 3 months after procedure
Changes in ANP, FGF 23, GAL 3 levels (baseline vs. 3 m values)
Time frame: baseline vs. 3 m values
AF freedom
Time frame: Procedure to 6 months visit
Changes in strain function on TTE over time
Time frame: baseline TTE to 6 months control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Charles University, Czech Republic.
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 3 inclusion and 8 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Marek Hozman, MD (+420267161111, marek.hozman@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in LA function (strain) by MRI (baseline vs. 3m values) (time frame: Baseline MRI to 3 months after procedure). 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 23 Sep 2024.