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RecruitingNCT07809347BRADY-PFAUpdated Sep 9, 2026

Evaluation of the Factors Associated With BRADYcardia Following Pulmonary Vein Isolation Using Pulsed Field Ablation

An observational study in Atrial Fibrillation (AF), Pulsed Field Ablation and Bradycardia, sponsored by Wroclaw Medical University. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Wroclaw Medical University · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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 the detailed description

The following factors will be analyzed:

  • demographics
  • medical history
  • medications
  • echocardiographic data
  • baseline ECG
  • anaesthetic records
  • periprocedural data
02

Conditions studied

  • Atrial Fibrillation (AF)
  • Pulsed Field Ablation
  • Bradycardia
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Wroclaw Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients undergoing PVI using PFA for the treatment of atrial fibrillation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Pulmonary vein isolation performed with PFA

Exclusion criteria

Exclusion Criteria:

  • Permanent pacemaker
  • CRT device
  • Dual-chamber ICD
  • Cardiac tamponade
  • Acute stroke
  • Acute bleeding requiring surgical intervention
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Interventions

  • ProcedurePulmonary vein isolation

    Ablation of atrial fibrillation using pulsed field technology under general sedation.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Bradycardia requiring medical intervention

    Time frame: Day 1

  2. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 11 months is below that.

Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2026
First posted
Sep 9, 2026
StartActual
Jan 1, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07809347
Lead sponsor
Wroclaw Medical University
Responsible party
Piotr Niewinski, MD (Doctor, Wroclaw Medical University) — Principal investigator
First posted
Sep 9, 2026
Start date
Jan 1, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 9, 2026

Study contacts

Piotr Niewinski, MD PhD
Contact
pnsky@wp.pl
+48790423298

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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