NCT05539313

Brief Summary

Cather ablation of non-paroxysmal atrial fibrillation is less effective compared to paroxysmal atrial fibrillation. Therefore, new techniques have been developed, such as high-density mapping to determine areas of focal and rotational activities. The aim is to assess the clinical efficacy of ablation focal and rotational activities, and to assess the relation between the areas of focal and rotational activities with fibrosis of both atria assessed using magnetic resonance.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

September 10, 2022

Last Update Submit

February 14, 2023

Conditions

Keywords

atrial fibrillationcatheter ablationcardiac magnetic resonancehigh-density mapping

Outcome Measures

Primary Outcomes (2)

  • Sinus rhythm maintenance

    The freedom from atrial fibrillation

    1 year

  • MRI and high-density relation

    The relation between areas of location and rotational activities with atrial fibrosis location

    3 days

Interventions

Patients will undergo magnetic resonance imaging of both atria, and interventional high-density mapping of both atria.

Eligibility Criteria

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

Patients with non - paroxysmal, i.e. persistent or long-lasting persistent symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation

You may qualify if:

  • non-paroxysmal atrial fibrillation

You may not qualify if:

  • creatinine \> 120 umol/l
  • claustrofobia
  • pregnancy
  • mechanical valve
  • significant valve disease
  • left ventricular dysfunction, EF less than 35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of the department of arrhythmias

Study Record Dates

First Submitted

September 10, 2022

First Posted

September 14, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Protocol will shared after study initiation

Shared Documents
STUDY PROTOCOL

Locations