MODULAR ATP
Research type
Research Study
Full title
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
IRAS ID
298246
Contact name
Ursula Appl
Contact email
Sponsor organisation
Boston Scientific
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 1 months, 30 days
Research summary
This study is looking at the new modular cardiac rhythm management system for those patients that are at risk of ventricular tachycardia (VT). This is a new system that does not require electrical wires that are inserted into the heart. The system comprises two parts - The first is the subcutaneous implantable cardioverter defibrillator (S-ICD) which is implanted under the skin. The S-ICD is able to recognise fast heart rhythms and deliver a shock. The second part of the system is a small pulse generator that is implanted directly in the heart. This is called the Empower PG (Pulse Generator). The S-ICD is able to send a command to the Empower PG to request the delivery of small electrical pulses which have been shown to be effective in stopping VT without the need for a shock. The Empower PG is also able to deliver pulses that stimulate the heart in the event that the heart rate drops too low.
The MODULAR ATP study will monitor the safety of the EMPOWER PG and the combined system and also how effective the communication is between the two devices.
The data from this study will be used for regulatory market approvals in the UK (UKCA), Europe (CE) and the United States (FDA) along with other geographies as necessary.
REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0818
Date of REC Opinion
4 Jan 2022
REC opinion
Further Information Favourable Opinion