ACCESS-CRT
Research type
Research Study
Full title
Achieving Conduction System Activation with Leadless Left Ventricular Endocardial Pacing
IRAS ID
307507
Contact name
Christopher Aldo Rinaldi
Contact email
Sponsor organisation
Guys and St Thomas's NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Cardiac Resynchronisation Therapy (CRT) is a form of cardiac pacing used in the treatment heart failure. Conventionally CRT is delivered by implanted devices similar to normal pacemakers, where a battery under the skin is connected to leads running through the veins to pace both the right and left sides of the heart. There is evidence that CRT improves outcomes in certain patients with heart failure.
Unfortunately, some patients either do not improve with conventional CRT, or are unsuitable for the standard procedure due to blocked blood vessels, high infection risk or difficulty placing the left sided lead. In such patients, an alternative treatment option is implantation of a leadless pacing device, such as the WISE-CRT system (EBR Systems Inc.), which is implanted directly into the left side of the heart through the blood vessels in the groin, and is approved for use in patients with symptomatic heart failure where conventional CRT was unsuccessful or not possible.
This study is investigating a modified technique for WISE-CRT implantation where it is used to deliver a particular form of CRT known as Conduction System Pacing. This is where the device aims to resynchronise the heart by pacing the hearts own electrical pathways rather than the heart muscle.
This is a new technique, and the study aims to determine the safety, success rate and effectiveness of the procedure.
During and after the procedure additional tests will be performed which will give detailed data on the heart’s immediate and short term response to treatment.
Initial set up will be as a multicentre UK study with a recruitment target of 20 patients. Pending funding and contractual agreements the plan is to expand this internationally with a total recruitment target of 45 patients.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0901
Date of REC Opinion
25 Jan 2023
REC opinion
Further Information Favourable Opinion