Evaluation of the Factors Associated With BRADYcardia Following Pulmonary Vein Isolation Using Pulsed Field Ablation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWroclaw Medical University
About this trial
The study aims to identify factors associated with bradycardia during the hospital stay after ablation of atrial fibrillation performed with pulsed field technology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Permanent pacemaker
CRT device
Dual-chamber ICD
Cardiac tamponade
Trial population
Consecutive patients undergoing PVI using PFA for the treatment of atrial fibrillation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pulmonary vein isolation
Procedure/SurgeryAblation of atrial fibrillation using pulsed field technology under general sedation.
Treatment groups
No treatment groups listed
Trial outcomes
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 1Secondary outcomes
1
Bradycardia requiring medical intervention
Time frame
Day 12
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 2Sponsors and contacts
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Source ClinicalTrials.gov