A STUDY TO ASSES THE EFFICACY OF A LEADLESS PACEMAKER SYSTEM IN CARDIAC PATIENTS

ACUTE EVALUATION OF A NOVEL LEADLESS PACEMAKER SYSTEM

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021603

Enrollment

Registered

2019-10-11

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: I259- Chronic ischemic heart disease, unspecified

Interventions

Intervention1: CALYAN LEADLESS PACEMAKER: The Calyan leadless pacemaker system is an investigational device for the treatment of cardiac disorders requiring ventricular pacing. The principal component

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willing and capable of providing informed consent 2.Scheduled to undergo a non-emergency open heart surgical procedure 3.Chest anatomy suitable for implant, according to physician judgment

Exclusion criteria

Exclusion criteria: 1. Patients who are not anatomically suitable to receive a sub-xiphoidal implant 2.Patients with have previously undergone an open heart surgical procedure 3. Currently implanted with a cardiac pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization device

Design outcomes

Primary

Measure	Time frame
The number of patients with successful implantation of the leadless pacemaker. Successful implantation will be judged by the mechanical placement of the device under the xiphoid process using the insertion tool.Timepoint: After temporary implantation of the Calyan Leadless Pacemaker	—

Secondary

Measure	Time frame
The secondary efficacy endpoint will be the number of patients with successful pacing of the ventricle with the leadless pacemaker system.Timepoint: After Anatomical measurements and ventricular electrogram	—

Countries

India

Contacts

Public ContactApurv Swarup

Innovitae Clinical Research Services Pvt Ltd

prathap.vc@innovitae.in9400144281

Outcome results

None listed

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