Atrial FibrillationFIBRO-RISKNCT03757741
Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation
An observational study of Atrial Fibrillation and Atrial Inflammation, run by Cardio Med Medical Center at 1 site in Romania.
Trial summary
FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Inflammation
- What is being tested?
- Cardiac imaging tests and Venous blood samle collection
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 1 Feb 2019to 1 Feb 2022
- 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
- Adult, Older adult
Study population: Study population includes patients from a single center with paroxysmal and persistent atrial fibrillation, meeting inclusion and exclusion criteria and undergoing pulmonary vein isolation radiofrequency catheter ablation.
Who may be able to join
- Patients with non-valvular paroxysmal or persistent atrial fibrillation who undergo successful ablation of atrial fibrillation, either by cryoablation or by radiofrequency advanced 3D mapping system;
- Ability to provide informed consent;
- Patients aged at least 18 years;
Who cannot join
- Patients with valvular atrial fibrillation;
- Patients with acute coronary syndrome in the last 30 days
- Patients in whom atrial fibrillation is presumed to be caused by hyperthyreosis
- Patients with long-standing persistent or permanent atrial fibrillation;
- Unwillingness or incapacity to provide informed consent;
- Allergy to gadolinium contrast media;
Show all 12Show fewer
- Absolute or relative contraindications to magnetic resonance imaging
- Pregnancy or lactation;
- Women with childbearing potential in absence of any contraceptive treatment
- Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis;
- Active malignancy or malignancy within the last 5 year prior to enrollment;
- Conditions associated with an estimated life expectancy of under 2 years;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Inflammation-mediated Myocardial Fibrosis on the Risk of Recurrence After Successful Ablation of Atrial Fibrillation - the FIBRO-RISK Study
FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases, interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis at the level of left atrium and left ventricle. At the same time, the amount of epicardial fat will serve as an indirect marker of localized inflammation and will be determined at different levels in the heart (surrounding left atrium, right atrium or the entire heart), while ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the procedure. All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.
The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year post ablation, documented by either ECG or Holter monitoring.
Read more
The secondary endpoints of the study will be:
- rate of re-hospitalization
- rate of survival without relapse
- rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Read the detailed description
The prevalence of atrial fibrillation (AF) is on the rise, being the most frequent sustained supraventricular arrhythmia and a health issue by its increased morbidity and mortality. In most of the cases, myocardial tissue located at the level of the pulmonary veins represents the trigger for atrial fibrillation. The pathophysiology of AF is still incompletely understood, several studies suggesting that profibrotic and inflammatory processes have a crucial role in the development of AF. So far the success rate of AF ablation is not very high, reaching 70% in patients with paroxysmal AF and 50% in cases with persistent AF. Several risk factors for the occurrence and recurrence of AF have been described in the literature, including left atrial enlargement, left ventricular dysfunction, epicardial fat volume, and myocardial fibrosis caused by local atrial inflammation. What remains to be investigated is the relationship between these risk factors and the recurrence of AF after radiofrequency catheter ablation using advanced 3D mapping system.
This is a clinical prospective, descriptive, single-center study which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed Tirgu Mures, Romania. The duration of the study is 2 years which include the initial screening and the follow-up period for the recurrence of AF.
The study will include 100 subjects suitable for catheter ablation. Imaging biomarkers and laboratory analyses such as high sensitive C Reactive Protein (hsCRP), matrix metalloproteases (MMP), interleukin-6 (IL6) and N-Terminal Pro-B-Type Natriuretic Peptide (NT pro-BNP) will be determined in the first 24 hours after the procedure. The anatomy of pulmonary veins, atrial fibrosis, atrial volumes and the amount of epicardial fat will be evaluated and quantified with late gadolinium-enhancement cardiac magnetic resonance (LGE-CMR). All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.
The study will be conducted over a period of 2 years, in which patients will be examined at baseline, and will be followed-up for recurrence of AF.
All patients will sign an informed written consent and will be checked for the exclusion criteria prior to enrolment.
Study objectives:
Primary: To investigate the correlation between imaging markers provided by cardiac magnetic resonance (including the degree of left atrial and ventricular fibrosis, left and right atrial volume, epicardial fat tissue volume), inflammatory biomarkers, and the risk of AF recurrence post ablation.
Secondary: To investigate the correlation between structural remodeling of the left and right atrium, epicardial fat tissue volume and serum inflammatory biomarkers in patients with AF.
Study Timeline:
- Baseline (day 0)
- Obtain and document consent from participant on study consent form.
- Verify inclusion/exclusion criteria.
- Obtain demographic information, medical history, medication history, alcohol, and tobacco use history.
- Record results of physical examinations and 12-lead ECG.
- Collect blood specimens (complete blood count, biochemistry and inflammatory biomarkers).
- Imaging procedures: transthoracic 2-D echocardiography, late gadolinium-enhancement cardiac magnetic resonance
- Visit 1 (month 1,3,6,12)
- Record results of physical examinations, 12-lead ECG and medical history.
- Imaging procedures: transthoracic 2-D echocardiography
- Final study visit (month 12)
- Record results of physical examinations, medical history,12-lead ECG and determination of serum levels of inflammatory biomarkers and NT-proBNP
- Imaging procedures: transthoracic 2-D echocardiography
- End-point evaluation.
Study procedures:
- Medical history, clinical examination, laboratory tests (complete blood count, biochemistry, serum level of hs-CRP, MMP, IL6, and NT-pro-BNP);
- 12-lead ECG
- 2D transthoracic echocardiography with measurement of cardiac diameters, volumes, valvular function and regurgitation, pressure gradients, left ventricular systolic and diastolic function and ejection fraction.
- Late Gadolinium-Enhancement Cardiac Magnetic Resonance (LGE-CMR) with the evaluation of left and right atrial volume, the volume of epicardial adipose tissue, the degree of atrial and ventricular fibrosis
- Pulmonary vein isolation radiofrequency ablation with advanced 3D mapping system
Data collection: All the information will be collected in a database that consists of patient's background, medical history, medication, imaging features provided by cardiac ultrasound, Cardiac magnetic resonance and CMR imaging post-processing.
- Conditions
- Atrial Fibrillation, Atrial Inflammation
- Being tested
- Cardiac imaging tests, Venous blood samle collection
- Keywords
- atrial fibrillation recurrence, atrial volume, atrial fibrosis, epicardial adipose tissue, inflammatory biomarkers, late gadolinium-enhancement cardiac magnetic resonance, pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac imaging testsDiagnostic test
2D transthoracic echocardiography; Late gadolinium-enhancement cardiac magnetic resonance with the evaluation of pulmonary veins anatomy, atrial fibrosis, atrial volumes and the amount of epicardial fat will
Venous blood samle collectionDiagnostic test
Venous blood sample collection 1 day prior to the ablation procedure: Serum levels of high sensitive C Reactive Protein, Matrix metalloproteases, Interleukin-6, and N-Terminal Pro-B-Type Natriuretic Peptide.
| Study group | Role | What they receive |
|---|---|---|
| AF-SG 01 | Study subjects with atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation Receives: Diagnostic Test: Cardiac imaging tests; Diagnostic Test: Venous blood samle collection | |
| AF-SG 02 | Study subjects without atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation Receives: Diagnostic Test: Cardiac imaging tests; Diagnostic Test: Venous blood samle collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of AF recurrence after pulmonary vein isolation
The primary outcome measure will be represented by the rate of AF recurrence at 1 year post ablation, documented by either ECG or Holter monitoring.
Measured: 12 months
Secondary outcomes (3)
Rate of re-hospitalization
The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Measured: 12 months
Rate of survival without relapse
The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Measured: 12 months
Rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2022
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.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardio Med Medical Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Targu Mures, Romania, University Hospital of Targu Mures, Romania
- Responsible party
- Sponsor
- Investigators
- Szilamér Korodi, M.D., Principal investigator, University of Medicine and Pharmacy of Tirgu Mures, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757741
- Sponsor's protocol ID
- CM0318-FIR
- Acronym
- FIBRO-RISK
- Status last verified
- Jul 2020
- First submitted
- 25 Nov 2018
- Last updated
- 2 Aug 2022
- Results posted
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available for interested parties.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inflammation-mediated Myocardial Fibrosis on the Risk of Recurrence After Successful Ablation of Atrial Fibrillation - the FIBRO-RISK Study
- ClinicalTrials.gov ID
- NCT03757741
- Acronym / sponsor ID
- FIBRO-RISK / CM0318-FIR
- Conditions
- Atrial Fibrillation, Atrial Inflammation
- Keywords
- atrial fibrillation recurrence, atrial volume, atrial fibrosis, epicardial adipose tissue, inflammatory biomarkers, late gadolinium-enhancement cardiac magnetic resonance, pulmonary vein isolation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cardio Med Medical CenterIndustry (pharma, biotech, devices)
- Collaborators
- University of Targu Mures, Romania, University Hospital of Targu Mures, Romania
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 29 Nov 2018 (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.
FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases, interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis at the level of left atrium and left ventricle. At the same time, the amount of epicardial fat will serve as an indirect marker of localized inflammation and will be determined at different levels in the heart (surrounding left atrium, right atrium or the entire heart), while ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the procedure. All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.
The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year post ablation, documented by either ECG or Holter monitoring.
The secondary endpoints of the study will be:
- rate of re-hospitalization
- rate of survival without relapse
- rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Detailed description
The prevalence of atrial fibrillation (AF) is on the rise, being the most frequent sustained supraventricular arrhythmia and a health issue by its increased morbidity and mortality. In most of the cases, myocardial tissue located at the level of the pulmonary veins represents the trigger for atrial fibrillation. The pathophysiology of AF is still incompletely understood, several studies suggesting that profibrotic and inflammatory processes have a crucial role in the development of AF. So far the success rate of AF ablation is not very high, reaching 70% in patients with paroxysmal AF and 50% in cases with persistent AF. Several risk factors for the occurrence and recurrence of AF have been described in the literature, including left atrial enlargement, left ventricular dysfunction, epicardial fat volume, and myocardial fibrosis caused by local atrial inflammation. What remains to be investigated is the relationship between these risk factors and the recurrence of AF after radiofrequency catheter ablation using advanced 3D mapping system.
This is a clinical prospective, descriptive, single-center study which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed Tirgu Mures, Romania. The duration of the study is 2 years which include the initial screening and the follow-up period for the recurrence of AF.
The study will include 100 subjects suitable for catheter ablation. Imaging biomarkers and laboratory analyses such as high sensitive C Reactive Protein (hsCRP), matrix metalloproteases (MMP), interleukin-6 (IL6) and N-Terminal Pro-B-Type Natriuretic Peptide (NT pro-BNP) will be determined in the first 24 hours after the procedure. The anatomy of pulmonary veins, atrial fibrosis, atrial volumes and the amount of epicardial fat will be evaluated and quantified with late gadolinium-enhancement cardiac magnetic resonance (LGE-CMR). All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.
The study will be conducted over a period of 2 years, in which patients will be examined at baseline, and will be followed-up for recurrence of AF.
All patients will sign an informed written consent and will be checked for the exclusion criteria prior to enrolment.
Study objectives:
Primary: To investigate the correlation between imaging markers provided by cardiac magnetic resonance (including the degree of left atrial and ventricular fibrosis, left and right atrial volume, epicardial fat tissue volume), inflammatory biomarkers, and the risk of AF recurrence post ablation.
Secondary: To investigate the correlation between structural remodeling of the left and right atrium, epicardial fat tissue volume and serum inflammatory biomarkers in patients with AF.
Study Timeline:
- Baseline (day 0)
- Obtain and document consent from participant on study consent form.
- Verify inclusion/exclusion criteria.
- Obtain demographic information, medical history, medication history, alcohol, and tobacco use history.
- Record results of physical examinations and 12-lead ECG.
- Collect blood specimens (complete blood count, biochemistry and inflammatory biomarkers).
- Imaging procedures: transthoracic 2-D echocardiography, late gadolinium-enhancement cardiac magnetic resonance
- Visit 1 (month 1,3,6,12)
- Record results of physical examinations, 12-lead ECG and medical history.
- Imaging procedures: transthoracic 2-D echocardiography
- Final study visit (month 12)
- Record results of physical examinations, medical history,12-lead ECG and determination of serum levels of inflammatory biomarkers and NT-proBNP
- Imaging procedures: transthoracic 2-D echocardiography
- End-point evaluation.
Study procedures:
- Medical history, clinical examination, laboratory tests (complete blood count, biochemistry, serum level of hs-CRP, MMP, IL6, and NT-pro-BNP);
- 12-lead ECG
- 2D transthoracic echocardiography with measurement of cardiac diameters, volumes, valvular function and regurgitation, pressure gradients, left ventricular systolic and diastolic function and ejection fraction.
- Late Gadolinium-Enhancement Cardiac Magnetic Resonance (LGE-CMR) with the evaluation of left and right atrial volume, the volume of epicardial adipose tissue, the degree of atrial and ventricular fibrosis
- Pulmonary vein isolation radiofrequency ablation with advanced 3D mapping system
Data collection: All the information will be collected in a database that consists of patient's background, medical history, medication, imaging features provided by cardiac ultrasound, Cardiac magnetic resonance and CMR imaging post-processing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF-SG 01 | – | Diagnostic Test: Cardiac imaging tests, Diagnostic Test: Venous blood samle collectionStudy subjects with atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation |
| AF-SG 02 | – | Diagnostic Test: Cardiac imaging tests, Diagnostic Test: Venous blood samle collectionStudy subjects without atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population includes patients from a single center with paroxysmal and persistent atrial fibrillation, meeting inclusion and exclusion criteria and undergoing pulmonary vein isolation radiofrequency catheter ablation.
Key inclusion criteria (3 listed)
- Patients with non-valvular paroxysmal or persistent atrial fibrillation who undergo successful ablation of atrial fibrillation, either by cryoablation or by radiofrequency advanced 3D mapping system;
- Ability to provide informed consent;
- Patients aged at least 18 years;
Key exclusion criteria (12 listed)
- Patients with valvular atrial fibrillation;
- Patients with acute coronary syndrome in the last 30 days
- Patients in whom atrial fibrillation is presumed to be caused by hyperthyreosis
- Patients with long-standing persistent or permanent atrial fibrillation;
- Unwillingness or incapacity to provide informed consent;
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 |
|---|---|---|
| Cardiac imaging tests2D transthoracic echocardiography; Late gadolinium-enhancement cardiac magnetic resonance with the evaluation of pulmonary veins anatomy, atrial fibrosis, atrial volumes and the amount of epicardial fat will | Diagnostic test | AF-SG 01, AF-SG 02 |
| Venous blood samle collectionVenous blood sample collection 1 day prior to the ablation procedure: Serum levels of high sensitive C Reactive Protein, Matrix metalloproteases, Interleukin-6, and N-Terminal Pro-B-Type Natriuretic Peptide. | Diagnostic test | AF-SG 01, AF-SG 02 |
Primary outcome
The rate of AF recurrence after pulmonary vein isolation
Time frame: 12 months
The primary outcome measure will be represented by the rate of AF recurrence at 1 year post ablation, documented by either ECG or Holter monitoring.
3 secondary outcomes
Rate of re-hospitalization
Time frame: 12 months
Rate of survival without relapse
Time frame: 12 months
Rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available for interested parties.
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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.
Szilamér Korodi, M.D. principal investigator
University of Medicine and Pharmacy of Tirgu Mures, Romania
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 and Atrial Inflammation, run by Cardio Med Medical Center at 1 site in Romania.
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 12 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: finished, as of the sponsor's last update on 2 Aug 2022. 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 Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate of AF recurrence after pulmonary vein isolation (time frame: 12 months). 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 2 Aug 2022.