NCT05862038

Brief Summary

Our study will include consecutive patients undergoing pulsed field ablation (PFA) or cryoballoon (CBA) ablation. Tissue injury and inflammation markers will be measured before and after the procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

February 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

May 7, 2023

Last Update Submit

May 17, 2023

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures

    One year

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population includes patients who are diagnosed with symptomatic paroxysmal or persistent atrial fibrillation and who are scheduled to undergo catheter ablation.

You may qualify if:

  • Symptomatic paroxysmal or persistent atrial fibrillation.
  • Age between 18 and 75 years.

You may not qualify if:

  • Prior atrial fibrillation ablation.
  • History of significant bleeding or thromboembolic events within the last 6 months.
  • History of severe renal or liver disease.
  • History of malignancy within the last 5 years.
  • History of autoimmune disease or immunodeficiency.
  • Significant mitral stenosis or other significant valvular heart disease.
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Dubrava

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Jordan

    University Hospital Dubrava

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Jordan

CONTACT

00385986113086anazovko4@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 7, 2023

First Posted

May 17, 2023

Study Start

February 10, 2023

Primary Completion

July 10, 2024

Study Completion

September 10, 2024

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)