Health Condition 1: I259- Chronic ischemic heart disease, unspecified
Conditions
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
Sponsors
CALYAN CARDIAC THERAPEUTICS INDIA PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 or above 2.Willing and capable of providing informed consent 3.Admitted to a cardiac intensive care unit 4.Indicated for implantation of a temporary cardiac pacemaker
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not eligible to be enrolled in the study: 1. Patients who are not anatomically suitable to receive a sub-xiphoidal implant, as determined by chest x-ray 2. Patients with complete AV block, or otherwise are pacemaker-dependent 3. Patients with have previously undergone an open heart surgical procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint will be the incidence of procedure and device-related complications. Timepoint: The primary efficacy endpoint will be the number of patients with successful chronic pacing of the ventricle at 3 months, including successful implantation and chronic capture of the ventricle. | — |
Secondary
| Measure | Time frame |
|---|---|
| uccessful implantation will be judged by the mechanical placement of the device under the xiphoid process and positioning of the electrodes on the epicardial surface of the heart.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactApurv Swarup
Innovitae Clinical Research Services Pvt Ltd
Outcome results
None listed