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TRIAL FOR EVALUATING THE EFFICACY OF A NEW LEADLESS DEFIBRILLATOR SYSTEM

ACUTE EVALUATION OF A NOVEL LEADLESS DEFIBRILLATOR SYSTEM - CT-06

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/04/042267
Enrollment
5
Registered
2022-04-28
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: I279- Pulmonary heart disease, unspecified

Interventions

Intervention1: Calyan Leadless Defibrillator System: The device being studied is a investigational device. The device will contain two FlexArm electrodes connected to an externalized lead with a DF-4

Sponsors

CALYAN CARDIAC THERAPEUTICS INDIA PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female or male 2. Age 18 or above 3. Willing and capable of providing informed consent 4. Scheduled for ICD implantation

Exclusion criteria

Exclusion criteria: 1. Patients with have previously undergone an open heart surgical procedure 2. Currently implanted with a cardiac pacemaker, implantable cardioverter defibrillator, cardiac resynchronization, or neurostimulation device

Design outcomes

Primary

MeasureTime frame
Efficacy endpoint will be the number of patients with successful defibrillation of the ventricle with the leadless defibrillation system.Timepoint: VISIT 2—

Secondary

MeasureTime frame
Secconary endpoint will be the number of patients with successful defibrillation of the ventricle with the leadless defibrillation system.Timepoint: Visit 2—

Countries

India

Contacts

Public ContactApurv Swarup

Innovitae Clinical Research Services Pvt Ltd

prathap.vc@innovitae.in

Outcome results

None listed

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