Atrial Fibrillation (AF)BRADY-PFANCT07809347
Evaluation of the Factors Associated With BRADYcardia Following Pulmonary Vein Isolation Using Pulsed Field Ablation
An observational study of Atrial Fibrillation (AF) and Pulsed Field Ablation, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The study aims to identify factors associated with bradycardia during the hospital stay after ablation of atrial fibrillation performed with pulsed field technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Pulsed Field Ablation, Bradycardia
- What is being tested?
- Pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2026to 31 Dec 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Consecutive patients undergoing PVI using PFA for the treatment of atrial fibrillation.
Who may be able to join
- Pulmonary vein isolation performed with PFA
Who cannot join
- Permanent pacemaker
- CRT device
- Dual-chamber ICD
- Cardiac tamponade
- Acute stroke
- Acute bleeding requiring surgical intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Institute of Heart Diseases, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556
Piotr Niewinski, MD PhD, pnsky1@gmail.com
About this study
Official title: Evaluation of the Factors Associated With Bradtycardia Following Pulmonary Vein Isolation Using Pulsed Field Ablation
The study aims to identify factors associated with bradycardia during the hospital stay after ablation of atrial fibrillation performed with pulsed field technology.
Read the detailed description
The following factors will be analyzed:
- demographics
- medical history
- medications
- echocardiographic data
- baseline ECG
- anaesthetic records
- periprocedural data
- Conditions
- Atrial Fibrillation (AF), Pulsed Field Ablation, Bradycardia
- Being tested
- Pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
Ablation of atrial fibrillation using pulsed field technology under general sedation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus bradycardia <50 beats/min on arrival at the recovery unit, defined as a sinus heart rate <50 beats/min on the first ECG obtained upon arrival
Measured: Day 1
Secondary outcomes (2)
Bradycardia requiring medical intervention
Measured: Day 1
Sinus bradycardia <50 beats/min, defined as a sinus heart rate <50 beats/min on the ECG obtained the next day after ablation
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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 (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Niewinski, MD, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809347
- Sponsor's protocol ID
- BRADY-PFA
- Acronym
- BRADY-PFA
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Factors Associated With Bradtycardia Following Pulmonary Vein Isolation Using Pulsed Field Ablation
- ClinicalTrials.gov ID
- NCT07809347
- Acronym / sponsor ID
- BRADY-PFA / BRADY-PFA
- Conditions
- Atrial Fibrillation (AF), Pulsed Field Ablation, Bradycardia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Sep 2026 (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.
The study aims to identify factors associated with bradycardia during the hospital stay after ablation of atrial fibrillation performed with pulsed field technology.
Detailed description
The following factors will be analyzed:
- demographics
- medical history
- medications
- echocardiographic data
- baseline ECG
- anaesthetic records
- periprocedural data
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing PVI using PFA for the treatment of atrial fibrillation.
Key inclusion criteria (1 listed)
- Pulmonary vein isolation performed with PFA
Key exclusion criteria (6 listed)
- Permanent pacemaker
- CRT device
- Dual-chamber ICD
- Cardiac tamponade
- Acute stroke
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 |
|---|---|---|
| Pulmonary vein isolationAblation of atrial fibrillation using pulsed field technology under general sedation. | Procedure or surgery | – |
Primary outcome
Sinus bradycardia <50 beats/min on arrival at the recovery unit, defined as a sinus heart rate <50 beats/min on the first ECG obtained upon arrival
Time frame: Day 1
2 secondary outcomes
Bradycardia requiring medical intervention
Time frame: Day 1
Sinus bradycardia <50 beats/min, defined as a sinus heart rate <50 beats/min on the ECG obtained the next day after ablation
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 (AF) and Pulsed Field Ablation, run by Wroclaw Medical University 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 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: looking for participants now, as of the sponsor's last update on 9 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Niewinski, MD PhD (+48790423298, pnsky@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinus bradycardia <50 beats/min on arrival at the recovery unit, defined as a sinus heart rate <50 beats/min on the first ECG obtained upon arrival (time frame: Day 1). 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 9 Sep 2026.