Examination of Fibrillation Atria Using Magnetic Resonance Imaging and Endocardial High-density Mapping
The Investigation and Analysis of Atria of Patients With Non-paroxysmal Atrial Fibrillation Using High-desnity Mapping and Cardiac Magnetic Resonance Imaging
1 other identifier
observational
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2022
Typical duration for all trials
1 active site
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
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 15, 2023
February 1, 2023
2.1 years
September 10, 2022
February 14, 2023
Conditions
Keywords
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- Shared Documents
- STUDY PROTOCOL
Protocol will shared after study initiation