TRIAL FOR EVALUATING THE EFFICACY OF A NEW LEADLESS DEFIBRILLATOR SYSTEM

Not yet recruiting

• Conditions: Pulmonary heart disease, unspecified,

• Registration Number: CTRI/2022/04/042267
• Lead Sponsor: CALYAN CARDIAC THERAPEUTICS INDIA PVT LTD

Brief Summary

This is A prospective, multi-site, single-arm, open-label feasibility study. This study is designed to evaluate the efficacy implant procedure and placement of the Calyan leadless defibrillator, and to evaluate the feasibility of defibrillation.Subjects Scheduled for ICD implantation will be recruited in the study.The device will be connected to anexternal defibrillator or ICD pulse generator, and defibrillation testing (ventricularfibrillation induction and cardioversion) will be performed.



The data from this study will be used to refine the device design, and to justify further investigation of the leadless defibrillation system.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-04-28
• Study Start: 2022-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Female or male 2.
• Age 18 or above 3.
• Willing and capable of providing informed consent 4.
• Scheduled for ICD implantation.

Exclusion Criteria

• Patients with have previously undergone an open heart surgical procedure 2.
• Currently implanted with a cardiac pacemaker, implantable cardioverter defibrillator, cardiac resynchronization, or neurostimulation device.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
defibrillation of the ventricle with the leadless defibrillation system.	VISIT 2
Efficacy endpoint will be the number of patients with successful	VISIT 2

Secondary Outcome Measures

Name	Time	Method
Secconary endpoint will be the number of patients with successful	defibrillation of the ventricle with the leadless defibrillation system.

Trial Locations

Locations (1)

Metromed International Cardiac Centre; 🇮🇳 Kozhikode, KERALA, India

Metromed International Cardiac Centre

🇮🇳Kozhikode, KERALA, India

Prof Dr V Nandakumar

Principal investigator

8592851444

prof.nandakumarv@gmail.com