Last reviewed · How we verify
NCT05821465: ALERT
Ambulatory Leadless Electrocardiogram Recorder Trial Feasibility
trial testing HeartWatch in Arrhythmias, Cardiac in 144 participants. Completed in 18 July 2024.
18 July 2024
Quick facts
| Lead sponsor | HelpWear Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 144 |
| Start date | 1 July 2023 |
| Primary completion | 18 July 2024 |
| Estimated completion | 18 July 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- HeartWatch
Conditions studied
- Arrhythmias, Cardiac — all drugs for Arrhythmias, Cardiac →
- Palpitation — all drugs for Palpitation →
- Syncope — all drugs for Syncope →
- Light Headedness — all drugs for Light Headedness →
Sponsor
HelpWear Inc.
Who can join
22 and older, any sex, with Arrhythmias, Cardiac or Palpitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today. The main question\[s\] it aims to answer are: 1. Does the HeartWatch recording allow characterization of tagged and abnormal arrhythmia events that are equivalent to the existing Event Recorder and Holter devices? 2. Does the HeartWatch recording allow for detection of QRS complexes that are equivalent to the predicate Holter lead I reference signal? Participants who have been recommended to receive a heart monitor for heart rhythm assessment will asked to wear the HeartWatch armband monitor at the same time as the standard heart monitor. They will be asked to flag symptoms (if they occur) on either the HeartWatch or on the Helpwear Smartphone. When their monitoring session for the standard heart monitor is complete, then the monitoring session for the HeartWatch armband is also complete.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05821465
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HeartWatch
Trials testing the same drug.
- NCT06164808 — Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch · NA · active not recruiting
- NCT05357716 — Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial · completed
Other recruiting trials for Arrhythmias, Cardiac
Currently open trials in the same condition.
- NCT07276139 — PACEVALUE: Development of a Risk Score to Predict Pacing-Induced Cardiomyopathy in Patients Undergoing Pacemaker or ICD · active not recruiting
- NCT06954610 — Cardiac Assessment for Recurrent Stroke Risk Evaluation in Atrial Fibrillation · recruiting
- NCT06360939 — Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease · NA · recruiting
- NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
- NCT06358391 — To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Pu · NA · recruiting
Other HelpWear Inc. trials
Trials by the same sponsor.
- NCT06164808 — Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch · NA · active not recruiting
- NCT05357716 — Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05821465 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HelpWear Inc.
- Last refreshed: 22 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05821465.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing