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Clinical trail protocol design for BeatX Device

Clinical Evaluation and Validation of the BeatX Holter/ELR/MCT Device - BEATX HOLTER

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/111379
Enrollment
246
Registered
2026-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

X ELEMENTS HEALTH PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient with indications for BeatX device for MCT and or Holter test Male & Female subject whose heart electrically activity to be recorded under MCT and or Holter.

Exclusion criteria

Exclusion criteria: Children below 2 years of age Pregnant Women Critically ill and unconscious patient Specially abled People above the age of 75 years

Design outcomes

Primary

MeasureTime frame
To collect clinical data of patient having ECG changes and evaluation of arrhythmia detected using MCT or Holter monitoring.Timepoint: Approximately 180 days from the date of first enrollment.

Secondary

MeasureTime frame
To collect the data with use of BeatX device, clinical feedback from the investigator. Vital physiological parameters and measured by the BeatX device, feedback from the user, reflecting the ease of use with overall usability.Timepoint: Approximately 200 days from the date of first enrollment.

Countries

India

Contacts

Public ContactYashaswini ML

JSS Hospital

durudmcardio@gmail.com9731984514

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026