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

Phase 1

Completed

• Conditions: Health Condition 1: I259- Chronic ischemic heart disease, unspecified

• Registration Number: CTRI/2019/10/021603
• Lead Sponsor: CALYAN CARDIAC THERAPEUTICS INDIA PVT LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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