Conduction system Assessment using Physiological criTeria for Realtime Evaluation for Left Bundle Branch Pacing (CAPTURE-LBBP)

Authors
Category Primary study
Registry of TrialsAustralian New Zealand Clinical Trials Register
Year 2026
INTERVENTION: INTERVENTION ARM (LPAC arm): Pacemaker implantation using Left Bundle Branch Area Pacing (LBBAP) with the TorqView device (LPAC — Electrical‐only medical device connection adaptor, single‐use; Trade name: TorqView; Manufacturer: Actis Medical Pty Ltd; ARTG No. 65159). TorqView is adminsterred by the implanting clinician who connects it to the pacing lead during the implant procedure. The TorqView provides continuous, beat‐by‐beat real‐time electrical signal monitoring during lead placement, allowing the implanting physician to assess electrical connectivity in real time throughout the procedure. TorqView is used for the duration of the pacemaker lead implantation ( 30minutes). Adherence to the intervention will be observed through the patient 'pacemaker implant form' where all devices used duirng the procedure are recorded. CONDITION: Bradycardia requiring permanent pacemaker implantation; ; Bradycardia requiring permanent pacemaker implantation Cardiovascular ‐ Other cardiovascular diseases PRIMARY OUTCOME: (i)Change in R‐wave peak time in Lead V6, as an electrical marker of synchronisation[All procedural electrogram recordings and ECG data are anonymised and exported from the electrophysiology laboratory recording system (Lab System Pro, Bard) to a centralised core laboratory. Measurements of the primary endpoint (R‐wave peak time) and other electrocardiographic parameters are performed by qualified electrophysiologists who are blinded to treatment allocation. A minimum of two independent blinded assessments are performed per participant. Endpoint is verified at patient device follow‐up clinic visit after acquiring device parameters and ECG. ] SECONDARY OUTCOME: 6 Minute Walk Test Distance[6 minute walk test distance 6 months post implant procedure] Change in left ventricular ejection fractin (LVEF). [Echo at baseline (pre‐procedure) and 6‐months Baseline (pre‐procedure), and 6 months echocardiogram post procedure. ] Fluoroscopy dose used for implant[Dose of fluoroscopy used in procedure is recorded based on output derived by patient record from the x‐ray machine used in the procedure. Offline, post‐procedure] Known complications are those that are know relating to pacemaker device‐related implant complications; bruising, bleeding, infection, or lead movement.[Review of medical records Offline, post procedure] Procedure durration[Procedure report Offline, post procedure] Quality of LIfe[EQ‐5D‐5L Baselline, 6 months post implant procedure] Successful physiological left bundle branch (LBB) capture at the end of the inde Xprocedure as measured by decremental pacing after lead deployment to observe transition from non‐selective to selective LBB capture[This will be a binary endpoint (Yes/No) adjudicated by independent, blinded ECG adjudicators using predefined, stringent electrocardiographic (ECG) criteria defined in current LBBAP consensus statement Offline, post‐procedure] INCLUSION CRITERIA: Inclusion: Patients will be considered eligible to participate in the study if: (i) aged greater or equal to 18 years of age (ii) written informed consent (iii) willing to be randomised (iv) are being implanted with a lumenless LBBP pacing lead as part of their care.
Epistemonikos ID: 7872352708d0c8d5b099da7954c730a8c61f252e
First added on: Aug 31, 2026