NCT06123130Completed
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study
Source: ClinicalTrials.gov · Last updated 5 Jul 2024
Brief summary (registry, in English)
The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 198 (actual)
- First submitted
- 5 Nov 2023
- Start date
- 13 Mar 2024
- Primary completion date
- 20 Jun 2024
- Lead sponsor
- HeartBeam, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT06123130
What you commit to
- Study type: Interventional
- Participants enrolled: 198
- From 13 Mar 2024 to the primary completion date, 20 Jun 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Open chest wounds or recent (\<30 days) surgery to the chest or abdomen.
Other illness
- Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol.
Who the study is looking for
- Male or female subjects over 18 years of age.
- Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions:
- Previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation.
- Patients with symptoms indicative of cardiac arrhythmias.
- Able and willing to sign informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Piedmont Heart Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| The Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Allegheny Health Network Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Long Island Jewish Medical Center Coordinator of this site? Confirm its status | Queens | United States | Unknown status |
| Atlanta Heart Specialists Coordinator of this site? Confirm its status | Tucker | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.