Fluoroless Conduction System Implant

NCT07094217 | Not Yet Recruiting

• 1 other identifier: 23HH8384
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pacemaker; Conduction System Pacing

Keywords

fluoroless; conduction system pacing; left bundle area pacing

Outcome Measures

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.

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

Secondary Outcomes (2)

• Change in fluoroscopy time

  From time of first patient recruited to the time of last patient recruited in the validation cohort upto 52 weeks

• Change in complication rates

  From time of first patient recruitment to the 1 year after last patient recruited

Study Arms (3)

Derivation

These patients will undergo the research protocol. In these patients, we will attempt to implant a permanent conduction system pacing lead, in lieu of the RV or LV lead. The lead will be implanted by operators who have implanted more than 40 leads to overcome the learning curve.

Validation

An optimised work flow will be derived using the information collected from the derivation cohort. Namely, the target areas for FAM and electro-anatomical maps will be determined, and the successful pattern of lead septum interaction on CARTO will be defined. The streamlined workflow will then be applied to 25 prospective patients. The success rates, procedure time, fluoroscopy time, capture threshold, number of attempted lead deployments and complication rates will be assessed.

Control

The control arm will consist of 25 patients undergoing a conduction system pacemaker using conventional pacing methods, with the same pacing indications as the study arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of patients referred for a cardiac pacemaker at Imperial College Healthcare Trust.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Officials

• Zachary Whinnett, BM.BS

  Imperial College London, Imperial College Healthcare Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akriti Naraen, MBChB

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 30, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07