1 in 8
new small-molecule drugs approved by the FDA from September 2023 to September 2026 carried a QTc-prolongation warning at approval (12 of 94).
Rhizome AI analysis of FDA review documents, September 2026
Clinical Trials & Pharma
ECG analytics for drug development, from feasibility to study read-out.
Cardiolyse gives sponsors and CROs a device-neutral, CE Class IIa ECG analytics engine for patient identification, risk stratification, treatment-response tracking and cardiac safety read-outs — delivered as a controlled study service with traceable outputs.
Study ECGs · one locked configuration
0
ECG parameters available per recording
1–12 leads
Resting, Holter and wearable ECG input
CE Class IIa
Medical device software under EU Regulations
0+
Years of ECG analytics R&D
Trusted by our commercial and project partners
Why cardiac safety data matters
The heart remains a central question in drug development.
New medicines still reach approval with QTc warnings. Cardiovascular disease is under-represented in clinical research, yet it is still the leading cause of death in Europe. Consistent, centrally analysed ECG data helps studies characterise cardiac effects and report them with confidence.
4%
of clinical trials between 2017 and 2022 focused on cardiovascular disease, compared with 24% for oncology.
European Society of Cardiology, 2026
1 in 3
deaths across the EU are caused by cardiovascular disease, as are 1 in 5 premature deaths before age 65.
European Society of Cardiology, 2026
Where ECG supports a programme
One ECG signal, read for every stage of drug development.
The same analysis engine can serve different questions across a programme. Each use is scoped with you, so the outputs match the protocol and the evidence that supports them.
Patient identification
Use ECG findings and risk scores to help find participants who may benefit from a therapy, at screening or from existing datasets.
Risk stratification
Group participants by ECG-derived risk, such as the Risk of Heart Disorders score, independently validated for heart failure outcomes.
Treatment response
Track ECG and HRV changes over repeated recordings to follow disease progression and response to treatment.
Cardiac safety read-outs
Rhythm findings and interval measurements, including QT, across every visit — for review by your cardiac-safety team or core lab.
Dataset re-analysis
Harmonise historical ECG data from different devices and sites, and re-analyse it with one consistent configuration.
Remote and decentralised capture
Accept recordings from 1- to 12-lead devices at home or on site — or use a wearable from our device partners.
Devices + analytics
Not sure which wearable fits your study? We bring one.
If you have not chosen an ECG device yet, Cardiolyse can offer a joint solution: a wearable from our device partners, matched to your protocol, plus the analytics behind it — one set-up instead of two separate suppliers.
Device partner
Beurer handheld ECG devices that participants can use at home for short, repeated recordings — already used with Cardiolyse in home-monitoring programmes and pilots.
Device partner
Corsano wrist-worn wearables for longer-term remote monitoring, for studies that follow participants continuously between visits.
Device partner
Compact Movesense body-worn ECG sensors for ambulatory and activity-based recordings, in the clinic or in daily life.
- Device matched to the protocol — we help choose the wearable by leads, recording length and participant setting.
- Integration done — recordings flow from the device to Cardiolyse analytics without extra work for your sites.
- One point of contact — devices and analytics coordinated together for the study.
How we engage
Start with a defined question. Scale what works.
Most programmes begin with a bounded, fixed-scope project on data you already hold. It proves the fit before anything is built into a live protocol.
Start here
Feasibility study
A retrospective analysis of your existing ECG dataset against a specific development question, with a written report and a QC package.
- Fixed scope and deliverables
- Native digital ECG files first
- Results you can take to a go / no-go decision
Study service
Study analytics
Protocol-defined ECG analysis for an ongoing or planned study, with the algorithm and configuration locked for the study.
- Same criteria for every site and visit
- Structured exports for your statistics team
- Works alongside your CRO or core lab
Partnership
Biomarker co-development
Joint work on ECG-derived biomarkers for a disease area, from exploration on retrospective data to prospective validation.
- Access to 300 ECG parameters
- Shared validation plan
- Publication-ready methods
For most studies, the ECG is a safety checkbox.
We see it as one of the richest signals a trial collects. With consistent, automated analytics, the same recordings that confirm safety can also reveal how a therapy affects the heart.
What sponsors receive
Traceable from source file to result.
Every output can be traced back to the recording, the configuration and the algorithm version that produced it.
Inputs
Native digital ECG
- 12-lead resting ECG
- 1- to 3-lead Holter recordings
- Wearable and patch ECG
- Source files and metadata preserved
- Unsupported inputs rejected and logged
Outputs
Study-ready data
- Structured JSON and CSV exports
- PDF reports per recording
- Rhythm findings, intervals and HRV
- Risk scores where in scope
- QC and audit package
Controls
Built for regulated work
- CE Class IIa medical device software
- ISO 13485 quality management
- ISO 27001-aligned security
- GDPR & HIPAA-aligned data handling
- EU-hosted processing
How it works
From protocol question to delivered dataset.
-
01
Scope
We agree the question, the ECG data, the outputs and who reviews what — before any processing starts.
-
02
Lock
The algorithm version and study configuration are fixed and documented for the whole study.
-
03
Process
Recordings are quality-checked, analysed and logged. Defined outputs go to independent review where the protocol needs it.
-
04
Deliver
You receive structured exports, reports and the QC and audit package for your statistical analysis.
Evidence
Scores tested in independent research.
Clinical research
Cardiolyse Risk of Heart Disorders score predicts heart failure outcomes in the MyoVasc study
At the University Medical Center Mainz, the RoHD score predicted worsening heart failure and all-cause death, independently of NT-proBNP and the MAGGIC score.
Read the study summary
Analytics
Heart Risks & HRV Analytics
The ECG-derived risk scores and HRV metrics that can be used as study read-outs.
See the scores
Integration
ECG API & Integration
A documented REST API for batch processing and structured results inside your study systems.
See the API
Frequently asked
Clinical trials and pharma, answered.
Do you replace our ECG core lab?
No. Cardiolyse supplies the ECG analytics, the consistency and the traceability. Your CRO or core lab keeps adjudication, trial-data operations, medical oversight and regulatory submission responsibilities.
Can we start with data we already have?
Yes. A retrospective feasibility study on an existing, lawfully held ECG dataset is the usual first step. It answers one defined question before any prospective work.
Which ECG data can you process?
Native digital ECG files are preferred: 12-lead resting ECG, 1- to 3-lead Holter and wearable or patch recordings. Each study defines its supported inputs, and anything outside them is rejected and logged.
We have not chosen an ECG device yet. Can you help?
Yes. Cardiolyse can offer a joint solution: a wearable from our device partners, such as Beurer, Corsano or Movesense, matched to your study needs, together with the analytics — coordinated as one set-up.
How do you keep results consistent across a study?
The algorithm version and configuration are locked for the study and documented. Every result is traceable to the source recording and the settings used.
Are the risk scores validated for our indication?
Validation depends on the score and the population. The Risk of Heart Disorders score has independent evidence in heart failure. For other uses, we agree a fit-for-purpose validation plan as part of the study.
How is participant data protected?
Processing runs in the EU with GDPR & HIPAA-aligned data handling and ISO 27001-aligned security, under the data processing terms agreed for the study.
For everything else, see the full FAQ.
Have an ECG question in your programme?
Tell us about the study and the data. We will propose a scoped first step.