Solutions to the Challenges of Conduction System Pacing
Trial statusRecruiting
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. Unfortunately, these pacemakers can only be implanted by a small group of experts at specialised centres with specialist equipment. This study aims to allow conduction system pacemakers to be offered to any patient at any hospital by simplifying the process of inserting the pacemaker wires and the improving the pacemaker's ability to interpret electrical traces.
Firstly, the best locations in the heart for conduction system pacemaker wires using specialised electrical traces, MRI and ultrasound scans will be identified. Features that can be seen on X-ray to guide doctors to these locations will then be identified. Secondly, the investigators will collect electrical information from the pacemaker wires and additional electrical traces to develop an algorithm that can make the interpretation the electrical traces more accurate.
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
Patients from London who are attending Hammermsith Hospital for device therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: Derivation
Group B: Validation
Group C: 2-lead ECG group
Trial outcomes
Primary outcomes
1
A1: Success rates of conduction system lead implant (novel workflow vs conventional methods)
Time frame
From enrollment until 6 months after recruitment of last patient2
B1: The number of patients with morphology change seen during decrementing output threshold test of 2-lead ECG when compared to gold standard 12-lead ECG
Time frame
From enrollment until 6 months after recruitment of last patientSecondary outcomes
1
A2: Procedure and fluoroscopy times of the streamlined workflow to current conventional methods of His-bundle and Left-bundle pacing
Time frame
From enrolment to until completion of PPM insertion of the last patient recruited into Study A (patient 100); average total of 3 years2
A2: Procedure and fluoroscopy times of the streamlined workflow of conduction system implant to current right ventricular pacing
Time frame
From enrolment to until completion of PPM insertion of the last patient recruited into Study A (patient 100); average total of 3 years3
A2: Assess capture threshold of conduction system pacing from the optimised workflow to that of conventional methods of conduction system implantation
Threshold is measured through the device, looking to achieve the minimum energy (in V) required to safely and reliably capture the cardiac tissue target. In this outcome, the investigators will compare the minimum threshold required to achieve capture of conduction system pacing to that of conventional right ventricular pacing and asses if this the same, higher or lower.
Time frame
From enrollment until 6 months after recruitment of last patient4
A2: Define left bundle area capture diagnostics and delineate differences between left ventricular septal pacing.
Time frame
From enrollment until 6 months after recruitment of last patientSponsors and contacts
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Source ClinicalTrials.gov