Not Yet RecruitingNot Applicable

Fluoroless Conduction System Implant

75 participantsStarted 2025-07-30

Plain-language summary

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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Successful conduction system lead implantation with a fluoroless implant protocol

Timeframe: From time of first patient recruited to the last patient recruited in the in the derivation cohort, upto 52 weeks

Trial details

NCT IDNCT07094217

SponsorImperial College London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-30

Contact for this trial

Akriti Naraen, MBChB

+91203-31-31000 a.naraen@imperial.ac.uk

View on ClinicalTrials.gov More Pacemaker trials