HeartBeam Announces Positive Heart Attack Pilot Study Results at TCT 2026: Patient-Recorded 3D ECG Shown to Be as Accurate as Standard 12-Lead ECG
Business Wire•02/11/2026•08:31 ET
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Key Highlights
- ➤HeartBeam showed 81.8% specificity versus 71.4% for standard 12-lead ECG in ACS assessment
- ➤STEMI sensitivity reached 82.9%, comparable to 83.8% for standard 12-lead ECG
- ➤Eight cardiologists interpreted HeartBeam recordings more consistently than standard ECGs
- ➤100% of 132 patients successfully recorded their own ECGs without prior training
- ➤U.S. pivotal study planned for Q1 2027; heart attack use remains investigational
Expert Statements
Graham Nichol, MD, MPH, FRCP(C), University of Washington
“Obtaining a clinically meaningful recording of the heart’s electrical activity at the time of symptom onset could help physicians assess whether a patient may be experiencing a heart attack and reduce time to intervention.”
Graham Nichol, MD, MPH, FRCP(C), University of Washington
“In the ALIGN-ACS pilot study, patients were able to record their own ECGs with the HeartBeam device under clinical supervision.”
Graham Nichol, MD, MPH, FRCP(C), University of Washington
“A cardiologist’s review of that patient-recorded ECG could help patients at home decide whether to seek care.”
Graham Nichol, MD, MPH, FRCP(C), University of Washington
“These early findings demonstrate the potential of this technology to help shorten time to care for patients experiencing a heart attack.”
Branislav Vajdic, Ph.D., Founder and President of HeartBeam
“Today, patients with chest pain or other symptoms are largely limited to self-assessment of whether they are experiencing a heart attack or not, as there is no portable, on-demand device available to them.”
Branislav Vajdic, Ph.D., Founder and President of HeartBeam
“The ALIGN-ACS pilot study results support our goal of providing accurate cardiac information to both patients and physicians remotely when symptoms occur, with the intent to help expedite the symptom-to-door time and reduce the lag between symptoms and care.”
HeartBeam Announces Positive Heart Attack Pilot Study Results at TCT 2026: Patient-Recorded 3D ECG Shown to Be as Accurate as Standard 12-Lead ECG
* Device demonstrated higher specificity than standard 12-lead ECG (81.8% vs. 71.4%), with comparable sensitivity
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