A Multicentre Registry on Remote monitoring of Cardiac Implantable Electronic Devices – Analysis of Feasibility and Efficacy in Indian population.

Primary objective:

·       To evaluate the feasibility and safety of remote monitoring in Indian population

·       To identify the utility of remote monitoring in terms of early identification of device related malfunctions with daily

transmissions from CardioMessenger® Smart

·       To analyze the benefits of remote monitoring resulting in early device optimization with daily transmissions from

CardioMessenger® Smart

·       To analyze the influence of remote monitoring in avoiding in hospital device interrogation visits with daily transmissions

from CardioMessenger® Smart

Secondary objective:

To identify the technical difficulties involved in remote monitoring in India

·       To identify the remote monitoring unit related malfunctions

·       To evaluate the acceptance of remote monitoring technology in all patients who undergo CIEDs and also evaluate the

satisfaction of the patients and the physician by obtaining feedback at the end of the registry.

·       To evaluate the battery consumption and success rate of daily remote monitoring transmissions

**Procedural Description:**All the patients implanted with CIEDs (irrespective of age of implant) that are compatible with Home Monitoring® who are willing to acquire the remote monitoring unit and willing to provide consent shall be enrolled into the registry. The initial acceptance to remote monitoring technology is analyzed. Upon enrolment onto the registry, the clinical data, implantation details and device data at the time of implant and/or prior to discharge is documented. The first remote monitoring transmission is performed in the hospital on the day of enrolment. The routine pacemaker clinic follow up is avoided. The patient would be called to the pacemaker clinic only if reprogramming of the device is warranted. The clinical evaluation is as per the discretion of the treating investigator and the frequency of visits and their clinical details are documented.

The remote monitoring transmissions are automatic and are transmitted every day by 2:00am. The data is analysed based on the alerts received from the Home Monitoring® service centre. The parameters to be monitored and the severity of alerts from the device needs to be programmed as specified in the protocol at the time of enrolment. The decision made by the treating physician on treatment for each alert received for every patient is documented. In case of an event requiring medical/device optimization, the event is expected to be documented and reported on the same day.

All the data documented will be collected in paper CRF.