Post-Market Clinical Data Analysis With Skanrays Defibrillators (Clinical study to record the safety and performance data of Skanrays Defibrillators in real world scenario)

A prospective, post-market clinical data analysis in patients undergoing cardioversion or defibrillation using Skanrays Defibrillators

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/05/053279

Enrollment

Registered

2023-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Health Condition 1: R001- Bradycardia, unspecified Health Condition 2: I468- Cardiac arrest due to other underlying condition Health Condition 3: I462- Cardiac arrest due to underlying cardiac condition Health Condition 4: I469- Cardiac arrest, cause unspecified Health Condition 5: I482- Chronic atrial fibrillation Health Condition 6: I480- Paroxysmal atrial fibrillation Health Condition 7: I481- Persistent atrial fibrillation Health Condition 8: I489- Unspecified atrial fibrillation and atrial

Interventions

Intervention1: Not Applicable: Not Applicable Intervention2: Defibrillation: External defibrillation Intervention3: Cardioversion: Synchronized cardioversion Intervention4: Pacing: Transcutaneous paci

Eligibility

Inclusion criteria

Inclusion criteria: Data from the subject that meets the below-mentioned criteria shall be collected. ? Patients with indications for defibrillation/cardioversion/pacing. ? Male and female subjects who weigh above 10 kg.

Exclusion criteria

Exclusion criteria: ? Unsafe conditions or surroundings for the use of Direct Current ? Contraindications for defibrillation A A responsive patient with spontaneous breathing and a palpable pulse. B Asystole or pulseless electrical activity PEA ? Contraindications for cardioversion - arrhythmias due to enhanced automaticity, such as digitalis toxicity of digitalis-associated tachycardia, sinus tachycardia, multifocal atrial tachycardia and junctional tachycardia. Catecholamine-induced arrhythmia having a homogeneous depolarization state Eg CPVT, shall be excluded. ? Contraindications for pacing - asymptomatic subjects with a reasonably stable rhythm.

Design outcomes

Primary

Measure	Time frame
To collect clinical data of patients undergoing defibrillation, cardioversion or pacing using Skanrays Defibrillators.Timepoint: Within 1 day.	—

Secondary

Measure	Time frame
To collect the following data with the use of Skanray defibrillators a. Clinical feedback from the investigator. b. Vital physiological parameters (including ECG, NIBP, SPO2) as measured by Skanrays Defibrillators. c. Feedback from the user reflecting the ease of defibrillation, cardioversion, pacing and overall usability. d. The evidence pertaining to defibrillation, cardioversion, and pacing in the given subject.Timepoint: Within 7 days	—

Measure

Time frame

To collect the following data with the use of Skanray defibrillators a. Clinical feedback from the investigator. b. Vital physiological parameters (including ECG, NIBP, SPO2) as measured by Skanrays Defibrillators. c. Feedback from the user reflecting the ease of defibrillation, cardioversion, pacing and overall usability. d. The evidence pertaining to defibrillation, cardioversion, and pacing in the given subject.Timepoint: Within 7 days

—

Countries

India

Contacts

Public ContactVasundhara R

JSS Hospital

manjappam@jssuni.edu.in7899584676

Outcome results

None listed

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