Atrial Fibrillation Clinical Trial
Official title:
Silent Atrial Fibrillation - Screening of High-risk Groups for Atrial Fibrillation (The Silence Study)
The primary aim of the present study is to screen high-risk type 2 diabetes patients and
heart failure patients without any history of atrial fibrillation (AF), ongoing oral
anticoagulation (OAC) treatment, implanted device or recent stroke/Transient Ischemic Attack
(TIA), for silent AF.
Moreover, we aim to establish the prevalence of two or more risk factors for stroke in
patients with heart failure and diabetes mellitus type 2 (DM2) with the aim of assessing the
feasibility for this group to undergo AF screening.
Overall, the aim of the study is to prevent stroke in high-risk patients groups through
identification of silent (asymptomatic) atrial fibrillation.
The number of screened patients with respectively heart failure and type 2 diabetes with a
risk score (Congestive Heart Failure, Hypertension, Aged 75 years or older, Diabetes, Stroke
/ transient cerebral ischemia, Vascular disease, Aged 65 years or older and Sex category
(CHADSVASc)) of two or more, the number of these patients excluded due to AF or ongoing AF,
the number of eligible patients not included for other reasons, and, finally, number of
included patients will be listed.
Patients eligible for screening will be supplied with a hand-held ECG-recorder developed by
Zenicor Medical Systems (www.zenicor.com) and will transmit recordings 4 times daily
(morning, midday, evening -at meals - and before bedtime) and in case of symptoms, for 14
days.
The transmitted ECGs will be digitally stored, analyzed and screened for AF. All AF episodes
will recorded and the day and time of the arrhythmia will be registered.
Eligible patients will be given brief oral and the more thorough written patient information
about the study, and offered an appointment for the first meeting, which will happen in the
Cardiological out-patient clinic in Copenhagen University Hospital (Hvidovre) with a member
of the project group. During the first meeting, the patient will get more information about
the study and has the possibility to ask questions. If the patient wants to bring a relative
or friend already at this meeting, this can be arranged. If the patient meets the criteria
and is interested in participation he/she will be invited to participation in the study. The
patient gets the rest of the information material, i.e. written informed consent
declaration, and is given a period for questioning and consideration of participation for at
least three days. If the patient wants another visit for further information and possibly
with participation of a relative or friend, such a visit is scheduled, and the patient can
be included at this visit, and written informed consent declaration can be given to the
project group member.
Heart failure patients will have a standardized echocardiography and diabetes patients will
have supplementary registration of HbA1c, and latest blood glucose value. The latest level
of creatinine and creatinine clearance will be registered for all patients (DM2 and
congestive heart failure (CHF)).
Every patient is given a Study identification (ID) number and there will be a key file
linking this number and the patient ID; thus, the dataset is anonymized.
All ECG's will be analyzed using a soft ware based algorithm which has been developed in
order to exclude normal recordings (sinus rhythm without irregularities).
Patients with newly detected AF will be referred to the local cardiology out-patient clinic
or if present OAC clinic for treatment according to established guidelines including OAC
treatment. Here the patients will be informed about the options of OAC treatment, the
reasons why we want to offer it, including the risk of developing cerebral ischemic stroke,
precautions with this treatment and the risks connected to OAC treatment. The treatment with
OAC is not a part of the screening study.
;
Observational Model: Cohort, Time Perspective: Prospective
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 |