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ECG Synthesis Software for Cardiac Arrhythmias (VALID-ECG Trial)

N/A
Waitlist Available
Research Sponsored by HeartBeam, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

VALID-ECG Trial Summary

This trial will test a new medical device for heart arrhythmias in adult patients in cardiology clinics.

Who is the study for?
This trial is for adults over 18 with a history of arrhythmias like atrial fibrillation or rapid heartbeat, who can consent to participate. It's not for those with recent chest surgery or conditions that make the study unsafe for them.Check my eligibility
What is being tested?
The AIMIGo 12L ECG Synthesis Software is being tested in this study to see how well it detects different types of heart rhythm problems when patients visit cardiology offices or Arrhythmia Clinics.See study design
What are the potential side effects?
Since the intervention involves non-invasive monitoring using Vectorcardiography (VECG), there are no direct side effects associated with drugs or invasive procedures.

VALID-ECG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite endpoint measured as differences in intervals/durations and amplitudes between standard 12L ECG and AIMIGo synthesized 12L ECG taken simultaneously
Secondary outcome measures
Clinical diagnostic accuracy

VALID-ECG Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinic.

Find a Location

Who is running the clinical trial?

Meditrial USA Inc.UNKNOWN
6 Previous Clinical Trials
2,580 Total Patients Enrolled
HeartBeam, Inc.Lead Sponsor
Peter J Fitzgerald, MDStudy ChairStanford University Medical School

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for those interested to participate in this research?

"Unfortunately, this clinical trial is no longer recruiting patients. As seen on clinicaltrials.gov, the posting was initially made on March 1st 2024 and last updated November 8th 2023. Fortunately, there are 702 other trials in search of participants at this time."

Answered by AI

Who else is applying?

What site did they apply to?
Northwell Health
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Need to explore all studies regarding my condition , AFIB. . This hopefully will monitor it regularly or daily.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
2024. "AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06123130.
~132 spots leftby Oct 2024
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