Atrial FibrillationNCT05862038
Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation
An observational study of Atrial Fibrillation, run by Ana Jordan at 1 site in Croatia.
Trial summary
Our study will include consecutive patients undergoing pulsed field ablation (PFA) or cryoballoon (CBA) ablation. Tissue injury and inflammation markers will be measured before and after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 10 Feb 2023to 10 Sep 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients who are diagnosed with symptomatic paroxysmal or persistent atrial fibrillation and who are scheduled to undergo catheter ablation.
Who may be able to join
- Symptomatic paroxysmal or persistent atrial fibrillation.
- Age between 18 and 75 years.
Who cannot join
- Prior atrial fibrillation ablation.
- History of significant bleeding or thromboembolic events within the last 6 months.
- History of severe renal or liver disease.
- History of malignancy within the last 5 years.
- History of autoimmune disease or immunodeficiency.
- Significant mitral stenosis or other significant valvular heart disease.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Our study will include consecutive patients undergoing pulsed field ablation (PFA) or cryoballoon (CBA) ablation. Tissue injury and inflammation markers will be measured before and after the procedure.
Read the detailed description
Study population:
The participants with symptomatic atrial fibrillation scheduled for PFA or CBA procedures Biomarkers of interest: high-sensitive troponin, CRP, NT-proBNP Data collection: Blood samples will be collected at baseline, immediately after the procedure, 24 hours after, and three months after.
Statistical analysis:
Comparisons of biomarker levels between PFA and CBA groups.
Results:
Comparison of biomarker levels between PFA and CBA groups at each time point. Changes in biomarker levels over time within each group. Correlation analysis between biomarker levels and clinical outcomes, such as AF recurrence, LA stiffness, complications, and hospitalization.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start10 Feb 2023
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Sep 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.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ana Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ana Jordan, University Hospital Dubrava
- Investigators
- Ana Jordan, Principal investigator, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862038
- Sponsor's protocol ID
- KBD01
- Status last verified
- May 2023
- First submitted
- 7 May 2023
- Last updated
- 19 May 2023
- 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 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation
- ClinicalTrials.gov ID
- NCT05862038
- Acronym / sponsor ID
- KBD01
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ana JordanUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 17 May 2023 (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.
Our study will include consecutive patients undergoing pulsed field ablation (PFA) or cryoballoon (CBA) ablation. Tissue injury and inflammation markers will be measured before and after the procedure.
Detailed description
Study population:
The participants with symptomatic atrial fibrillation scheduled for PFA or CBA procedures Biomarkers of interest: high-sensitive troponin, CRP, NT-proBNP Data collection: Blood samples will be collected at baseline, immediately after the procedure, 24 hours after, and three months after.
Statistical analysis:
Comparisons of biomarker levels between PFA and CBA groups.
Results:
Comparison of biomarker levels between PFA and CBA groups at each time point. Changes in biomarker levels over time within each group. Correlation analysis between biomarker levels and clinical outcomes, such as AF recurrence, LA stiffness, complications, and hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients who are diagnosed with symptomatic paroxysmal or persistent atrial fibrillation and who are scheduled to undergo catheter ablation.
Key inclusion criteria (2 listed)
- Symptomatic paroxysmal or persistent atrial fibrillation.
- Age between 18 and 75 years.
Key exclusion criteria (7 listed)
- Prior atrial fibrillation ablation.
- History of significant bleeding or thromboembolic events within the last 6 months.
- History of severe renal or liver disease.
- History of malignancy within the last 5 years.
- History of autoimmune disease or immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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.
Ana Jordan principal investigator
University Hospital Dubrava
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 Ana Jordan at 1 site in Croatia.
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 2 inclusion and 7 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 19 May 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 Croatia. 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 Ana Jordan (00385986113086, anazovko4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures (time frame: One year). 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 19 May 2023.