Atrial FibrillationDIPENCT06381245
First-time Ablation of Atrial Fibrillation Registry
An observational study of Atrial Fibrillation and Arrhythmia, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia
- What is being tested?
- PPG-based remote heart rhythm/rate monitoring, ECG-based remote heart rhythm/rate monitoring and Transthoracic and transesophageal echocardiography examination
- How many people
- 340 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2023to 30 Apr 2026
- How long will I take part?
- 12 Months
- 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: Patients undergoing first-time ablation (radiofrequency or pulsed field)
Who may be able to join
- paroxysmal or persistent AF
- first-time ablation of AF
Who cannot join
- patients unable to give informed consent
- serious health condition existing before ablation
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success.
The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers.
Read the detailed description
AF is a multifactorial disease influenced by many possible mechanisms. This study will examine several different predictors of successful AF ablation: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers. Analysis of these factors will help determine the optimal combination of predictors of successful ablation. This combination of prognostic factors can then be used to tailor therapeutic decisions specifically to individual patients and to improve patient selection for invasive treatment. Better patient selection and choice of ablation type can help increase success rates and avoid unnecessary procedures and their associated risks.
- Conditions
- Atrial Fibrillation, Arrhythmia
- Being tested
- PPG-based remote heart rhythm/rate monitoring, ECG-based remote heart rhythm/rate monitoring, Transthoracic and transesophageal echocardiography examination, Liver ultrasound examination, Rotational angiography with three-dimensional reconstruction
- Keywords
- Atrial fibrillation, Arrhythmia, Pulsed field ablation, Radiofrequency ablation, Catheter ablation, Prediction, Detection, Mobile Health, Telemedicine
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPG-based remote heart rhythm/rate monitoringDiagnostic test
PPG-based remote heart rhythm/rate monitoring
ECG-based remote heart rhythm/rate monitoringDiagnostic test
ECG-based remote heart rhythm/rate monitoring
Transthoracic and transesophageal echocardiography examinationDiagnostic test
Transthoracic and transesophageal echocardiography examination
Liver ultrasound examinationDiagnostic test
Liver ultrasound examination
Rotational angiography with three-dimensional reconstructionDiagnostic test
Rotational angiography with three-dimensional reconstruction
Blood-derived biomarker analysisDiagnostic test
Blood-derived biomarker analysis
Mobile health-based spirometryDiagnostic test
Mobile health-based spirometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Late AF recurrence
Late AF recurrence
Measured: 3-12 months after ablation
Secondary outcomes (13)
Late recurrence of AF or atrial tachycardia or atrial flutter
Late recurrence of AF or atrial tachycardia or atrial flutter
Measured: 3-12 months after ablation
Early recurrence of AF
Early recurrence of AF
Measured: <3 months after ablation
Early recurrence of AF or atrial tachycardia or atrial flutter
Early recurrence of AF or atrial tachycardia or atrial flutter
Measured: <3 months after ablation
Time to AF recurrence and the impact of early recurrence on late AF recurrence
Time to AF recurrence and the impact of early recurrence on late AF recurrence
Measured: <3 and 3-12 months after ablation
The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring
The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring
Measured: 3 months after ablation
Progression or regression of AF
Progression of AF (from paroxysmal to persistent or persistent to permanent) or regression of AF (from persistent to paroxysmal)
Measured: 3-12 months after ablation
Modification of treatment, including antiarrhythmic treatment
Modification of treatment, including antiarrhythmic treatment
Measured: 3-12 months after ablation
AF-related quality of life and symptoms
AF-related quality of life and symptoms
Measured: Before, 3 and 12 months after ablation
Periprocedural complications
Periprocedural complications (e.g. cardiac tamponade, vascular complications, pseudoaneurysm, arteriovenous fistula, stroke, transient ischemic attack)
Measured: Around ablation
Heart rate variability and rate
Heart rate variability and rate
Measured: <3 months after ablation
Blood biomarker levels
Blood biomarker levels
Measured: Before, 3 and 12 months after ablation
Ablation procedure parameters
Ablation procedure parameters (e.g. ablation time, procedure time, number of applications, amount of painkillers used)
Measured: At ablation
Cardiac remodelling
Cardiac remodelling based on transthoracic and transesophageal echocardiography parameters
Measured: Before, 3 and 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Dec 2023
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
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 FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- 340 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Gawałko, MD, PhD, Principal investigator, 1st Department of Cardiology, Medical University of WarsawPaweł Balsam, MD, PhD, Principal investigator, 1st Department of Cardiology, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381245
- Sponsor's protocol ID
- KB/265/2023
- Acronym
- DIPE
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krzowski B, Jablonska M, Gawlik M, Zaborska-Dworak M, Gawalko M, Marchel M, Lodzinski P, Balsam P, Grabowski M, Peller M. Perioperative parameters and myocardial necrosis: a real-world comparison of Farapulse and Varipulse. Cardiol J. 2026;33:e00226036. doi: 10.5603/cj.106769.
PubMed 41972517
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-time Ablation of Atrial Fibrillation Registry
- ClinicalTrials.gov ID
- NCT06381245
- Acronym / sponsor ID
- DIPE / KB/265/2023
- Conditions
- Atrial Fibrillation, Arrhythmia
- Keywords
- Atrial fibrillation, Arrhythmia, Pulsed field ablation, Radiofrequency ablation, Catheter ablation, Prediction, Detection, Mobile Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 24 Apr 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.
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success.
The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers.
Detailed description
AF is a multifactorial disease influenced by many possible mechanisms. This study will examine several different predictors of successful AF ablation: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers. Analysis of these factors will help determine the optimal combination of predictors of successful ablation. This combination of prognostic factors can then be used to tailor therapeutic decisions specifically to individual patients and to improve patient selection for invasive treatment. Better patient selection and choice of ablation type can help increase success rates and avoid unnecessary procedures and their associated risks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing first-time ablation (radiofrequency or pulsed field)
Key inclusion criteria (2 listed)
- paroxysmal or persistent AF
- first-time ablation of AF
Key exclusion criteria (2 listed)
- patients unable to give informed consent
- serious health condition existing before 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 |
|---|---|---|
| PPG-based remote heart rhythm/rate monitoringPPG-based remote heart rhythm/rate monitoring | Diagnostic test | – |
| ECG-based remote heart rhythm/rate monitoringECG-based remote heart rhythm/rate monitoring | Diagnostic test | – |
| Transthoracic and transesophageal echocardiography examinationTransthoracic and transesophageal echocardiography examination | Diagnostic test | – |
| Liver ultrasound examinationLiver ultrasound examination | Diagnostic test | – |
| Rotational angiography with three-dimensional reconstructionRotational angiography with three-dimensional reconstruction | Diagnostic test | – |
| Blood-derived biomarker analysisBlood-derived biomarker analysis | Diagnostic test | – |
| Mobile health-based spirometryMobile health-based spirometry | Diagnostic test | – |
Primary outcome
Late AF recurrence
Time frame: 3-12 months after ablation
Late AF recurrence
13 secondary outcomes
Late recurrence of AF or atrial tachycardia or atrial flutter
Time frame: 3-12 months after ablation
Early recurrence of AF
Time frame: <3 months after ablation
Early recurrence of AF or atrial tachycardia or atrial flutter
Time frame: <3 months after ablation
Time to AF recurrence and the impact of early recurrence on late AF recurrence
Time frame: <3 and 3-12 months after ablation
The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring
Time frame: 3 months after ablation
Progression or regression of AF
Time frame: 3-12 months after ablation
Modification of treatment, including antiarrhythmic treatment
Time frame: 3-12 months after ablation
AF-related quality of life and symptoms
Time frame: Before, 3 and 12 months after ablation
Periprocedural complications
Time frame: Around ablation
Heart rate variability and rate
Time frame: <3 months after ablation
Blood biomarker levels
Time frame: Before, 3 and 12 months after ablation
Ablation procedure parameters
Time frame: At ablation
Cardiac remodelling
Time frame: Before, 3 and 12 months after ablation
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 23 Jun 2026.
- Derived from this study: PubMed 41972517Krzowski B, Jablonska M, Gawlik M, Zaborska-Dworak M, Gawalko M, Marchel M, Lodzinski P, Balsam P, Grabowski M, Peller M. Perioperative parameters and myocardial necrosis: a real-world comparison of Farapulse and Varipulse. Cardiol J. 2026;33:e00226036. doi: 10.5603/cj.106769.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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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.
Monika Gawałko, MD, PhD principal investigator
1st Department of Cardiology, Medical University of Warsaw
Paweł Balsam, MD, PhD principal investigator
1st Department of Cardiology, Medical University of Warsaw
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 Arrhythmia, run by Medical University of Warsaw at 1 site in Poland.
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 2 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 23 Jun 2026. 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 Poland. 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?
Late AF recurrence (time frame: 3-12 months after ablation). 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 NCT06381245, 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 23 Jun 2026.