Fluoroless Conduction System Implant
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorImperial College London
About this trial
Conduction system pacing is a new way of stimulating the heart using pacemaker wires. Traditional pacemakers stimulate the heart muscle which causes disordered heart beats: the walls of the heart move at different times. This wears down the heart over time.
Conduction system pacemakers stimulate the heart's electrical system directly producing natural heart beats that are much less disordered. These pacemakers can be challenging to insert with different heart shapes, sizes and scars. This can increase procedure times and time exposed to xray as pacemakers are inserted using x-rays to guide where the lead is implanted.
This study aims to allow conduction system pacemakers to be implanted without the use of normal xray (fluoroscopy).
The investigators will create an anatomical shell of the heart using special plastic (mapping) catheters that is inserted within the heart from the groin. The investigators will use a special heart scanning (echo) catheter to see how the pacemaker wire is inserted into the heart muscle. The investigators will use MRI to confirm that the information we collect is accurate. Using this information the investigators will create a protocol to implant a lead that does not require xray, using only the mapping catheter.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a ventricular pacing indication: high grade atrioventricular block and symptomatic trifasicular, bifasicular block or left bundle branch block LBBB for cardiac resynchronisation therapy
Adults willing to take part (ages 18 - 100 years old)
Able to give consent.
Disqualifiers
Unable to give consent
Children age < 18 years and adults > 100 years old
Pregnant patients • As per standard of care, female patients of child-bearing age will have a urine pregnancy test prior to their procedure.
Trial population
The study population will consist of patients referred for a cardiac pacemaker at Imperial College Healthcare Trust.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
75 Participants
are grouped into 3 trial groupsGroup A: Derivation
Group B: Validation
Group C: Control
Trial outcomes
Primary outcomes
1
Successful conduction system lead implantation with a fluoroless implant protocol
The primary objective of this study is to develop a fluoroless implant protocol of conduction system leads using 3D electroanatomical mapping. Electroanatomical mapping will be used to understand the cardiac anatomy, removing the reliance on fluoroscopy to position the pacemaker lead. Successful conduction system lead implant rates will be assessed against a control arm utilising conventional fluoroscopic methods.
Time frame
From time of first patient recruited to the last patient recruited in the in the derivation cohort, upto 52 weeksSecondary outcomes
1
Change in fluoroscopy time
Is there a change in the overall procedure and fluoroscopy time with utilisation of targeted lead deployment.
Time frame
From time of first patient recruited to the time of last patient recruited in the validation cohort upto 52 weeks2
Change in complication rates
With better visualisation of the cardiac anatomy using the electroanatomical mapping, is there a change in complication rates
Time frame
From time of first patient recruitment to the 1 year after last patient recruitedLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: