ASD2 Study
Research type
Research Study
Full title
Acute Extravascular Defibrillation, Pacing and Electrogram Study (ASD2 Study)
IRAS ID
199327
Contact name
Griet Wouters
Contact email
Sponsor organisation
Medtronic Bakken Research Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 28 days
Research summary
Abnormally rapid heart rates are potentially life-threatening. Treatment(electric shock or a series of rapid electric pulses)can be delivered by an implantable cardioverter defibrillator (ICD). Typically, an 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, sometimes it is not possible or desirable to pass leads through veins, e.g. 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 electric shock therapy, and the device is larger than a conventional ICD. In addition, it cannot deliver a form of treatment called Anti-Tachycardia Pacing (ATP), which painlessly terminates lethal heart rhythms by delivering low-energy rapid electrical pulses. \nThis study aims to continue work in this area by testing whether a lead positioned behind the breastbone close to the heart can be used to observe the electrical signals of the heart (normal and abnormal) and be used to restore an abnormally rapid heart rate to normal. Results may assist future developments that may overcome the limitations of currently available systems.\nAs part of a group of 120 participants globally, individuals scheduled to undergo certain heart procedures as part of their clinical care will be invited to take part. The study will add approximately 50 minutes to the duration of the planned procedure and involves making a small incision near the breastbone, to temporarily position a lead 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. \nParticipant follow-up is between 7 and 50 days after the procedure, usually to coincide with the scheduled standard of care follow-up.\n
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0197
Date of REC Opinion
7 Jun 2016
REC opinion
Further Information Favourable Opinion