SYNSEQ, version 1.0
Research type
Research Study
Full title
Left Ventricular Synchronous versus Sequential Multi Spot Pacing for CRT\nSYNSEQ study
IRAS ID
197319
Contact name
Francisco LEYVA-LEON
Contact email
Sponsor organisation
Medtronic Bakken Research Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
For patients diagnosed with heart failure some are indicated to receive a cardiac resynchronization therapy(CRT)device as part of their treatment plan. A CRT device is a medical device which is designed to monitor and treat heart rhythm abnormalities. It records electrical signals inside the heart using leads (thin wires) placed inside the different chambers of the heart. The level of improved benefit or response to CRT can be dependent on the position of these leads.\nThe the purpose of the study is to evaluate the optimal lead positioning and pacing configuration in the lower left chamber (Left ventricle (LV))of the heart for patients indicated to receive a CRT device, by undergoing a research\nElectrophysiology (EP) study.\nThe CRT system is commercially available. This means it is CE marked: it is approved for use by the public and is accepted for use in patients who have cardiac pumping deficiency. In this study, a connection box will be used. This will allowphysician to test the contractility of the different parts of left ventricle. By this way, your physician will know which one has the best contractility abilities. The connection box being used in this study is investigational because it is not commercial available. This means that the connection box is not approved for use by the public.\nPatients whom are indicated to receive a CRT device will be approached to participate in the study and if they agree and after written consent has been obtained, they will be asked to attend a screening/baseline visit where they will\nundergo an:\nEchocardiogram(If not done in the last 3 months),Electrocardiogram (ECG) (if not done in the last 3 months), Blood\ntests, a Pregnancy test (If applicable) and a Magnetic Resonance Imaging (MRI) scan. The research EP study will take\nplace either on itself, immediately before a planned CRT implant or conjointly during an already planned routine EP\nstudy. The information obtained during the EP study will possibly present clinicians with more options of how tomanage their patients heart failure treatment regime and possibly help identify why some patients are unresponsive to\nCRT. In addition, it will be evaluated whether blood pressure measurements can be used to identify an individual’s\nresponse to CRT. Participation is expected to last between 1 and 21 days. Study exit will occur at the point of hospital\ndischarge after undergoing the research EP study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0088
Date of REC Opinion
25 Apr 2016
REC opinion
Further Information Favourable Opinion