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NCT Number: NCT07809347

Evaluation of the Factors Associated With BRADYcardia 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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulsed Field Ablation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Heart Diseases, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location status: Recruiting

Location contact

Piotr Niewinski, MD PhD

CONTACT

[email protected]

About this study

The following factors will be analyzed:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pulmonary vein isolation performed with PFA

Exclusion criteria

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

Treatment and study plan

pulmonary vein isolation

Procedure

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Niewinski, MD PhD

CONTACT

[email protected]

+48790423298

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

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

Acronym: BRADY-PFA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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