NCT07809347

Brief Summary

The study aims to identify factors associated with bradycardia during the hospital stay after ablation of atrial fibrillation performed with pulsed field technology.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

August 29, 2026

Last Update Submit

September 3, 2026

Conditions

Atrial Fibrillation (AF)Pulsed Field AblationBradycardia

Outcome Measures

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

    Day 1

Secondary Outcomes (2)

  • Bradycardia requiring medical intervention

    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

    Day 2

Interventions

Pulmonary vein isolationPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- Pulmonary vein isolation performed with PFA

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Heart Diseases, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationBradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Piotr Niewinski, MD PhD

CONTACT

+48790423298pnsky@wp.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 29, 2026

First Posted

September 9, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 9, 2026

Record last verified: 2026-09

Locations

PL(1)