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Clinical study of BIOCALCULUS, an ambulatory cardiac monitor.

Clinical validation study of BIOCALCULUS V.1.0: A novel cardiac rhythm recorder

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/09/027995
Enrollment
75
Registered
2020-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: I491- Atrial premature depolarization Health Condition 2: I484- Atypical atrial flutter Health Condition 3: I499- Cardiac arrhythmia, unspecified Health Condition 4: I482- Chronic atrial fibrillation Health Condition 5: I492- Junctional premature depolarization Health Condition 6: I492- Junctional premature depolarization Health Condition 7: I494- Other and unspecified premature depolarization Health Condition 8: I498- Other specified cardiac arrhythmias Health Condit

Interventions

None listed

Sponsors

Sonia Mohandas
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Informed written consent will be obtained from all the participants of the study. Two groups of patients will be studied 1)Patients undergoing 24hr Holter monitoring for arrhythmia detection will undergo simultaneously extended monitoring with BIOCALCULUS V 1.0 recorder-25 Patients. 2)Patients undergoing cardiac rehabilitation will be monitored using BIOCALCULUS V 1.0 recorder during and immediately after the rehabilitation program-50 Patients

Exclusion criteria

Exclusion criteria: Critically ill patients. Participants who in the opinion of the investigator may not be co-operative or otherwise not eligible for the study. Not willing to give consent for the study

Design outcomes

Primary

MeasureTime frame
Heart rhythmTimepoint: After collecting, the data will be analysed within 2 days and report will be compared with standard holter device. Beats will be checked against normal sinus rhythm and abnormalities will be determined.

Secondary

MeasureTime frame
Heart rateTimepoint: Check whether the heart rates falls within normal range. greater than 60 beats per minute and less than 100 beats per minute

Countries

India

Contacts

Public ContactDr Hafeesh Fazulu Rahman

Pushpagiri Medical College Hospital

hafeesh@gmail.com9995706688

Outcome results

None listed

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