Atrial Fibrillation Clinical Trial
Official title:
An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial to Determine the Optimal Anticoagulation Therapy for Patients Untergoing Catheter Ablation of Atrial Fibrillation
Study objective is to demonstrate that anticoagulation with the direct factor Xa inhibitor
apixaban is not less safe than Vitamin-K-antagonists (VKA) therapy in patients undergoing
catheter ablation of non-valvular AF in the prevention of peri-procedural complications.
The AXAFA trial will compare peri-ablational treatment with apixaban to peri-ablational
treatment wit VKA in a randomized trial of patients undergoing catheter ablation of atrial
fibrillation (AF).
AXAFA is an open-label trial designed to evaluate the safety and efficacy of two types of
anticoagulant therapy, VKA therapy and therapy with the direct factor Xa inhibitor apixaban,
in patients undergoing scheduled catheter ablation for AF. All patients will undergo the
ablation procedure after pre-treatment with an anticoagulant (either apixaban in the "Xa
group" or a vitamin K antagonist in the "VKA group").
Patients can undergo catheter ablation within the trial after at least 30 days of continuous
effective anticoagulation. Ablation can be performed earlier when or timely after exclusion
of atrial thrombi have been excluded by a clinically indicated by transthoracic
echocardioggram (TEE). After TEE continuous effective anticoagulation must be ensured until
the end of the trial.
In the MRI-substudy will be explored wether novel oral anticoagulants (NOAC) have the
potential to reduce clinically silent brain lesions after catheter ablation of AF.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |