SyncAV post market trial
Research type
Research Study
Full title
SyncAV Post-Market Trial
IRAS ID
278459
Contact name
Tim Betts
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 30 days
Research summary
Heart failure is characterised by the inability of the heart to pump enough blood to the vital organs. Patients with heart failure may benefit from a therapy that resynchronises the heart to pump blood using the ventricles more efficiently. SyncAV is a feature that works automatically to match the CRT device pacing with a patient’s own heartbeat. The SyncAV Post Market Trial is a prospective, randomized, multi-centre trial and will evaluate changes in the pumping volume of the left side of the heart (the left ventricular end-systolic volume) between baseline (before implant) and 12 months (post-randomization) in patients with cardiac resynchronization therapy (CRT) devices programmed with SyncAV (Arm 1) compared to patients with CRT devices programmed with a fixed AV delay programming (Arm 2). \nThe trial will include patients scheduled for implantation of an Abbott CRT pacemaker (CRT-P) or CRT defibrillator (CRT-D) and who meet all inclusion/exclusion criteria. Patients will be randomized in a 1:1 ratio between SyncAV CRT programmed ON (Arm 1) and fixed AV delay (Arm 2) within 2 – 6 weeks post successful CRT implant. \nParticipants will be followed up at Baseline, Implant, Randomization, Discharge, 3, 6, and 12 months. Data will be collected during routine hospital visits. Participants will have echo and ECGs, complete questionnaires. Demographics, physical information, programming information, medical and prescription history will be collected.\n\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0110
Date of REC Opinion
14 Oct 2020
REC opinion
Further Information Favourable Opinion