NCT05451797

Implant of the WiSE CRT System With an Intracardiac Pacemaker

A Feasibility Study Into the Implant of the WiSE CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a single arm, prospective, feasibility, multi-centre, observational study. Participants will be suitable for a Cardiac Resynchronisation Therapy (CRT) implant using Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy, known as the WiSE-CRT device system as well as requiring a pacemaker implant which will also be leadless. Some of these participants may also require an AV Node ablation. The purpose of this study is to assess the safety and efficacy of these two cardiac devices implanted in the order of operator preference (all implants undertaken on the same day or in a number of up to 4 separate sequenced implants/procedures).

Detailed description

Heart Failure is a serious condition in which the heart is unable to pump enough blood to meet the body's demands. Some heart failure occurs when the heart chambers pump in a desynchronised manner, reducing the amount of blood pumped with each heartbeat. The National Institute for Health and Care Excellence (NICE) recommends Cardiac Resynchronisation Therapy (CRT) for a subset of these patients. Patients undergoing CRT receive a special implantable pacemaker with an additional lead via the coronary sinus (CS) to synchronise the pumping of the heart chambers (ventricles). CRT works by pacing both the left \& right ventricles to ensure they pump at the same time. This in turn, reduces heart failure symptoms. CRT is an effective treatment for many patients, but limitations prevent some patients from benefiting: * 5-10% of patients are considered untreated due to acute/chronic issues with the CS lead * 30% of patients do not respond/improve The WiSE-CRT System is an implantable pacing system capable of delivering pacing energy to the heart without using a pacing lead. It was designed to address the persistent limitations of current CRT systems. The WiSE-CRT System operates alongside a co-implanted pacemaker or CRT system and replaces the pacing function of the CS lead. Intracardiac pacemakers are miniaturized, self-contained, pacing systems implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and pacing lead inserted into a vein. By co-implanting both the European conformity certificated (CE marked) WiSE-CRT system and a leadless intracardiac pacemaker, this pilot study will assess the safety and efficacy of implanting a totally leadless system, thereby avoiding both acute and chronic complications associated with the implant of transvenous pacing leads. This study is a single arm, prospective, multi-centre, observational study. Participants will have initial pre-implant screening baseline measurements prior to implantation of the first system, then will be followed up immediately post implant, then at 1 month \& 6 months post implant.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Implant of WiSE-CRT with intracardiac pacemaker	Implant of two cardiac devices

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-07-11
• Last updated: 2023-12-26

Regulatory

• FDA-regulated device study