None listed
Conditions
Brief summary
Left bundle area pacing is an emerging modality. The importance of continuous electrical monitoring during LBBAP pacemaker implantation has not been established. The CAPTURE trial analyses the principle that continouous electrical monitoring will improve acute implant physiological characteristics, and assesses the impact of implant electrical monitoring on clinical outcomes of pacemaker implantation.
Interventions
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, all
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.
Sponsors
Southern Adelaide Local Health Network (Flinders Medical Centre)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Patients will be excluded if they: (i) Under the age of 18 (ii) have a life expectancy considered to be less than 12 months (iii) Patients unable to provide informed consent for pacemaker implant, will be excluded from participation in the trial
Outcome results
None listed