NCT05716581

Brief Summary

The aim of the study is to find factors associated with sinus rhythm maintenance after catheter ablation for atrial fibrillation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

January 29, 2023

Last Update Submit

February 14, 2023

Conditions

Atrial FibrillationCatheter AblationSpectral AnalysisVectorcardiographyHeart Rate Variability

Outcome Measures

Primary Outcomes (1)

  • AF reoccurrence during follow-up

    AF freedom will be defined as freedom from atrial fibrillation or any other regular atrial tachycardia lasting \> 30sec. Rhythm monitoring will be done using regular Holter recordings

    1 year after the ablation

Interventions

Catheter ablationDEVICE

Catheter ablation for atrial fibrillation will be done according to the current medical praxis. Pulmonary vein isolation using either radiofrequency or pulsed-field ablation will be done in all patients. In patients with non-paroxysmal AF, additional ablation lesions (posterior wall ablation, roof or mitral isthmus line, ablation of complex fractionated atrial electrograms) could be done based on the operator´s discretion

Eligibility Criteria

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

All patients indicated for the catheter ablation for atrial fibrillation in our center will be enrolled.

You may qualify if:

  • atrial fibrillation

You may not qualify if:

  • absent of informed content

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

March 1, 2023

Primary Completion

December 31, 2025

Study Completion

March 1, 2026

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

AFter study completion, data will be available on the request.

Time Frame
After study completion