The TLC study. Version 1.1
Research type
Research Study
Full title
The TLC study: A feasibility study into the implant of the WiSE CRT System with an intracardiac pacemaker to achieve Totally Leadless CRT.
IRAS ID
311092
Contact name
Paul R Roberts
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
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 heart beat.
NICE recommends Cardiac Resynchronisation Therapy (CRT) for a subset of these patients. Patients undergoing CRT receive a special implantable pacemaker with an additional lead (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 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.REC name
London - Surrey Research Ethics Committee
REC reference
23/LO/0264
Date of REC Opinion
23 May 2023
REC opinion
Further Information Favourable Opinion