An interventional study of VitalPatch Device in Arrythmia, Cardiac, sponsored by Mercy Research. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-24.
Sponsored by Mercy Research · Not applicable, Interventional, and Supportive care
Among 337 studies in Arrhythmias, Cardiac with a site in United States — 50 open to participants now, 68 under way, none of them phase 3. Arrhythmias, Cardiac · United States.
Among the 337 studies in Arrhythmias, Cardiac with a site in United States, this one is the 170th largest by enrollment of the 182 interventional ones, is one of 31 that started in 2020, is one of 123 with no phase, and was the 220th registered.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
Browse Arrhythmias, Cardiac studies →50 of the 337 studies in Arrhythmias, Cardiac with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 167 Arrhythmias, Cardiac studies recruiting now, 118 (71%) set no upper age limit and 13 (8%) stop at 75 or younger; 31 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →337 studies; the count open now beside each. This study's row is marked.
First in 1983; this study’s year is marked. 31 started in 2020.
Median enrollment 77 across the 182 interventional studies, 133 across the 154 observational. Of the 231 that completed or were terminated, 91 (39%) have results posted.
133 of 337 have an industry lead sponsor. The 10 most frequent:
Mercy Research is the lead sponsor of 17 studies on the registry; none are open to participants now.
Mercy Research has 1 study filed under Arrhythmias, Cardiac — fewer than ten, so there is no comparison to draw.
27 of the studies in Arrhythmias, Cardiac with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06703489Medtronic Cardiac Ablation SolutionsSafety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) | 2026-11 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT06854081Elutia Inc.EluPro Antibiotic-Eluting BioEnvelope Registry | 2026-12 |
| NCT04520347University of California, Los AngelesIVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry | 2026-12 |
| NCT05371405Stanford UniversityMachine Learning in Atrial Fibrillation | 2026-12 |
Among the 337 studies in Arrhythmias, Cardiac with a site in United States, from their registry updates:
Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms.
This project intends to validate, through comparative study, the output of new technologies (ECG Interpretation and arrhythmia detection) to the VistaCenter platform, aiming to replace current telemetry monitoring equipment. The new technology, through the previous Mercy pilot study, has demonstrated greater accuracy in the detection of ventricular tachycardia patterns and other dysrhythmias/arrhythmias, as well as, reducing the volume of false alarms resulting in the mitigation of alarm fatigue experienced by bedside staff and monitor technicians.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Where a wearable biosensor is being considered for use in the health management of individuals at high-risk for poor health outcomes, and in the detection or prevention of adverse events within settings where traditional monitoring devices are not currently in use, the ECG interpretation will provide Arrhythmia detection which will help ensure that irregular rhythms will be reported quickly.
Diagnostic Test: VitalPatch Device
The VitalPatch® is an IRB (791130) and FDA approved wearable device that allows for the constant monitoring of biometric measurements and may have utility in the health management of individuals at high-risk for poor health outcomes and in the detection or prevention of adverse events within settings where more traditional telemetry monitoring devices are not currently in use.
Reduction in false alarms received from current telemetry monitoring technology
• Compare generation of false alarms with VitalPatch and current telemetry monitoring
Time frame: 6 months
Start is estimated for May 2020; primary completion for Nov 2020, 6 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mercy Research