Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG
Recruiting
N/AInterventional Study
Heart Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
81 (estimated)
Sponsor
L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône · Other
Who this trial is looking for
This trial is looking for patients who experience palpitations and need a cardiologist's help. Participants will wear a connected watch to help monitor their heart activity over time.
Are You a Good Fit for This Trial?
You may be able to join if
I have palpitations that require a cardiologist's consultation.
I do not have a previous diagnosis of arrhythmia unless my symptoms are different.
I agree to wear the connected watch except while charging.
I have a smartphone or tablet that can connect to the Health Mate app.
I am affiliated with a social security system.
I can provide a signed consent form.
You may not be able to join if
I refuse to wear the connected watch.
I have an implantable device like a pacemaker.
I have known arrhythmia with the same symptoms.
I am pregnant or breastfeeding.
I cannot follow the study because of geographical or psychological issues.
I am participating in another clinical trial.
I am under guardianship or deprived of liberty.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Palpitations are a frequent reason for consultation (16% of total volume) and management in the emergency department.
Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter, combined with a stress test if symptoms are triggered by physical activity.
The diagnostic difficulty lies in the frequency and duration of this transient symptom. At the time of co…
Palpitations are a frequent reason for consultation (16% of total volume) and management in the emergency department.
Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter, combined with a stress test if symptoms are triggered by physical activity.
The diagnostic difficulty lies in the frequency and duration of this transient symptom. At the time of consultation, the patient is often asymptomatic. The initial strategy is to demonstrate an electrocardiographic trace during the attack, in order to adapt management to the chosen etiology.
The HOLTER ECG is the gold standard, but it is not very cost-effective due to the infrequent and random nature of the onset of symptoms.
The advent of accessible connected tools such as connected watches seems to be an interesting alternative for acquiring a per-critical trace of symptoms. They are widely adopted by the general population, with ease of use by the individual and long monitoring times.
The main aim of the study is to establish the diagnostic cost-effectiveness of one or other of the two diagnostic strategies (rate of identification of the causal arrhythmia) at 6 months from the cardiological consultation.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Any patient consulting for the main reason of palpitations; without a previous diagnosis of arrhythmia, unless the current symptomatology appears different from that associated with the previous rythmological diagnosis;
* Palpitations requiring cardiological consultation or em…
Inclusion Criteria:
* Any patient consulting for the main reason of palpitations; without a previous diagnosis of arrhythmia, unless the current symptomatology appears different from that associated with the previous rythmological diagnosis;
* Palpitations requiring cardiological consultation or emergency hospital treatment;
* Absence of suggestive diagnosis on intercritical 12-lead ECG (pre-excitation, AVB M2/3, high-grade atrioventricular block, non-sustained tachyventricular, atrial fibrillation with heart rate; 110 per minute, atrial tachycardia or flutter);
* Non-contributory stress test (no electrical abnormality, occurrence of arrhythmia or reproduction of palpitations) if isymptoms occur during exercise;
* Accepts to wear the watch all the time outside the charging time;
* Using a personal smartphone or tablet compatible with the Health Mate application and with an Internet connection;
* Affiliated with a social security system ;
* Providing dated and signed an informed consent form.
Exclusion Criteria:
* Refusal to wear the connected watch;
* Refusal to use the watch provided for the study because they use a personal connected watch;
* Unable to use the connected watch (lack of understanding of its use and rationale);
* No smartphone;
* Wearer of an implantable device (PM, ICD);
* Already known and treated arrhythmia with identical symptoms;
* Heart disease with indication for primary/secondary prevention implantable device;
* Associated syncope;
* Obvious extra-cardiac cause;
* Pregnant or breast-feeding woman;
* Inability to undergo study follow-up for geographical, linguistic, social or psychological reasons;
* Participating in another clinical study which can interfere with this study
* Patient under guardianship or deprived of liberty.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.