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
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