SydÃ¤ntek ECG equivalence study: A randomized double blind controlled study to investigate the non inferiority of SydÃ¤ntek ECG versus conventional ECG machines for 12 lead ECGs, High frequency frequency ECGs (HFECG) and Ultra HFECG

The SEES Trials : Sydantek ECG Equivalence Study - SEES trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032733

Enrollment

250

Registered

2021-04-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I00-I99- Diseases of the circulatory system

Interventions

Intervention1: Sydantek ECG: Its a Diagnosis based study, we do not have any treatment involved Control Intervention1: Welch Allyn ECG Machine: CardioPerfect Workstation Resting ECG : 12 Lead PC Based

Eligibility

Inclusion criteria

Inclusion criteria: 1.Be informed of the nature of the study and will give written informed consent 2.Have body weights within 25% of the appropriate weight range 3.Be able to communicate effectively with study personnel 4.Subjects undergoing angioplasty (for 20 random patients from one cath lab with informed consent signed) 5.Subjects with CRT (10 patients from one EP centre with CRT deployed for LBBB followed by 50 more if data is deemed satisfactory)

Exclusion criteria

Exclusion criteria: 1.Loss of limbs which precludes accurate placement of ECG electrodes 2.Any significant tremors as in Parkinson or panic attack or any other condition which would induce ECG artefacts particularly in conventional ECG machines. 3.Subject not able to communicate with study personnel Subject unable to understand the consent form Absence of signed informed consent

Design outcomes

Primary

Measure	Time frame
Acquisition of 2 ECGs for each participant i.e Conventional ECG form Welch Allyn ECG Machine and Carditek ECG. Electrical equivalence will be performed on both the ECGs using Parameters like P wave, PR Interval, QRS voltage, QRS width, QTc Segment and ST segment. The 2 ECGs from each participant will be blinded for identification and submitted to peer cardiologist for clinical equivalence. Timepoint: All the analysis will start after 4 weeks from the start of trails	—

Measure

Time frame

Acquisition of 2 ECGs for each participant i.e Conventional ECG form Welch Allyn ECG Machine and Carditek ECG. Electrical equivalence will be performed on both the ECGs using Parameters like P wave, PR Interval, QRS voltage, QRS width, QTc Segment and ST segment. The 2 ECGs from each participant will be blinded for identification and submitted to peer cardiologist for clinical equivalence. Timepoint: All the analysis will start after 4 weeks from the start of trails

—

Secondary

Measure	Time frame
The acquired Carditek ECGs will be used for analysis of 1. High frequency changes in acute ischaemia 2. Ultra high frequency changes in CRT patients. Parameters used for analysis are sensitivity and capability of the device to pick low voltage signals, and subsequently for predictability of response of CRT. Timepoint: Two months from the trails start date.	—

Countries

India

Contacts

Public ContactAishwarya Srinivasan

Elbit Diagnostics

sugopal@loraxit.com9844110277

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026