ASD Study (Acute Substernal Defibrillation Study)
Research type
Research Study
Full title
Acute Substernal Defibrillation Study (ASD Study)
IRAS ID
160623
Contact name
Mark Hall
Contact email
Sponsor organisation
Medtronic Bakken Research Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
Although abnormally rapid heart rates are potentially life-threatening, treatment in the form of an electric shock or a series of rapid electric pulses can be delivered by an implantable cardioverter defibrillator (ICD). Typically, a conventional ICD is implanted under the skin of the chest near the shoulder, with electrical connecting leads running through the veins to the heart chambers. However, in some cases, passing the leads along the veins is either not possible or not desirable, such as when the veins are narrowed. Whilst an ICD system is available which avoids the use of veins by passing the leads under the skin, there are disadvantages: more energy is required to deliver therapy and the device is larger than a conventional ICD. In addition, it cannot deliver an important form of treatment known as Anti-Tachycardia Pacing (ATP), which is capable of painlessly terminating lethal heart rhythms by delivering low-energy electrical pulses.
The Medtronic sponsored study aims to begin to address these disadvantages by testing whether a lead positioned behind the breastbone close to the heart can be used to restore a an abnormally rapid heart rate to normal. If so, future developments may overcome some of the limitations of currently available systems.
As part of a group of forty participants globally, individuals scheduled to undergo certain heart procedures as part of their clinical care will be invited to take part. The procedure, lasting around 20 minutes, involves making a small incision near the breastbone, to position a lead temporarily close to the heart. Under controlled conditions, an abnormal, fast heart rhythm will be triggered followed by the delivery of an electric shock to restore the heart rhythm to normal. Standard safety equipment will be ready for immediate use if necessary.
Follow-up is carried out between 7 and 50 days after the procedure.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/1307
Date of REC Opinion
9 Dec 2014
REC opinion
Further Information Favourable Opinion