Heart Failure Clinical Trial
Official title:
Optimal Left Ventricular Lead Positioning During Cardiac Resynchronisation Therapy; Comparison of Two Methods of Targeting
Verified date | July 2019 |
Source | Cambridge University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cardiac Resynchronisation Therapy (CRT) is a well-known treatment for patients with heart
failure. It is a special pacemaker that consists of three pacing wires, which are implanted
in the right upper and bottom chambers of the heart and via a vein on the surface of the main
pumping chamber (left bottom chamber). CRT helps by improving co- ordination between the top
and the bottom chambers of the heart. By stimulating the heart from the left and right bottom
chambers, co-ordination can be restored and heart function as well as symptoms improve. It is
known that up to 30-40% of patients of patients undergoing CRT pacemaker implantation do not
attain any benefit. Given the inherent risks and costs of pacemaker implantation and
maintenance, a reduction in the rate of CRT "non-responders" is an important goal.
It has been suggested that presence of scar tissue in the heart and suboptimal placement of
the pacing wire on the top of the main pumping chamber can explain this poor response. The
best place to position the pacing wire on the surface of the main pumping chamber is the area
that contracts last and it can be identified using ultrasound scan of the heart.
Unfortunately, ultrasound is not always possible to help identifying the best area and only a
minority of hospitals are able to use this method. Therefore we aim to investigate
alternative ways of positioning the pacing wire in the best possible area of the main pumping
heart chamber. Investigators propose to measure electrical signals as an alternative and more
effective way in positioning the wire in the most effective area. Investigators aim to look
at the relationship between the best area identified by ultrasound scan and by electrical
signals and also use electrical signals to avoid areas of scar.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. LV Ejection Fraction = 35 % 2. New York Heart Association class I-IV 3. QRS =130ms 4. Left Bundle Branch Block 5. Male or female, aged 18 years or above 6. Able to give consent Exclusion Criteria: 1. Patients with Atrial Fibrillation 2. Unable to give consent 3. QRS=120 ms 4. Right Bundle Branch Block |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peter J Pugh |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Q-LV (electrical activation of the left ventricle) at different sites of the left ventricle | The time from onset of depolarisation (Q wave) to sensed electrogram in the left ventricle ("LV") will be measured at various sites over the left ventricular epicardium to build up a map of myocardial electrical activation | 1 day | |
Secondary | Mechanical activation of the left ventricle using echocardiography | The pattern of mechanical activation of the left ventricle will be determined using speckle-tracking echocardiography. | 1 day |
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