Atrial Fibrillation Clinical Trial
Official title:
Investigation of Substrates Associated With the Recurrence of Atrial Fibrillation After PV Cryoablation
The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include
Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses.
The aim of this study is to investigate the prevalence of each mechanism and if biomarkers
may be used to predict of these events.
Eighty patients with paroxysmal or persistent AF will undergo PV isolation with cryoablation
followed by loop recorder implantation. Patients in whom atrial tachyarrhythmias recur during
12 months follow-up (outside of the 3-month post procedure blanking window) will be offered a
second electrophysiology study (EP) study to assess PV isolation and non-PV focuses and
further ablation performed as required.
At baseline blood samples will be taken to investigate the correlation between specific
biomarkers and both the incidence and type of recurrence. The correlation between recurrence
of atrial tachyarrhythmias due to non-PV associated arrhythmic focuses and elevated baseline
levels of NT-ProBNP, CRP, TNF, MMP1 will be pre-specified.
40 consecutive patients will have a biopsy taken from the intraventricular and interatrial
septum to investigate the correlation between myocardial inflammation, the presence of
fibrosis and recurrence of atrial tachyarrhythmias. Correlation between biomarkers of
inflammation and biopsy-proven myocardial inflammation or fibrosis will be assessed.
The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include
Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses.
The aim of this study is to investigate the prevalence of each mechanism and if biomarkers
may be used to predict these events.
Eighty patients with paroxysmal or persistent AF will undergo PV isolation with cryoablation
followed by loop recorder implantation. Patients in whom atrial tachyarrhythmias recur during
12 months follow-up (outside of the 3-month post procedure blanking window) will be offered a
second EP study to assess PV isolation and non-PV focuses and further ablation performed as
required. Recurrence will be defined as an episode of atrial tachyarrhythmia (AF, atypical
atrial flutter, or atrial tachycardia) on loop recorder with a duration greater than 30
seconds or ECG document atrial tachyarrhythmia. The incidence of atrial tachyarrhythmia
recurrence, and its association with symptoms after the index PV cryoballoon isolation, will
be assessed.
At baseline blood samples will be taken to assess levels of N-terminal pro brain natriuretic
peptide (NT-proBNP), High-sensitivity C-reactive protein (high-sensitive CRP), Tumor Necrosis
Factor (TNF), Interleukin 1 beta (IL1B), Fatty acid binding protein (FABP), Matrix
metalloproteinase-1 (MMP1), Matrix metalloproteinase-3 (MMP3), Matrix metalloproteinase-9
(MMP9), Transforming growth factor beta 1 (TGF-beta1), Tissue inhibitor of metalloproteinases
1 (TIMP-1), Fibroblast growth factor 9 (FGF-9). Correlation between recurrence of atrial
tachyarrhythmias due to non-PV associated arrhythmic focuses and elevated baseline levels of
NT-ProBNP, CRP, TNF, MMP1 will be pre-specified. We will look with receiver operating
characteristic (ROC) curve analysis the level of biomarkers which predict recurrence of
atrial tachyarrhythmias with the best ratio between sensitivity and specificity.
40 consecutive patients will have a biopsy taken from the intraventricular and interatrial
septum to investigate the correlation between myocardial inflammation, the presence of
fibrosis and recurrence of atrial tachyarrhythmias. Correlation between biomarkers of
inflammation and biopsy-proven myocardial inflammation or fibrosis will be assessed.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
| Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
| 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 |