None listed
Conditions
Brief summary
This study looks at patients with heart failure who have a special type of pacemaker called CRT, but sadly aren't feeling much better. Researchers want to test if upgrading this pacemaker using a newer technique, called Left Bundle Branch Area Pacing (LBBAP), is a practical option for these patients. The main goal isn't to prove the upgrade works yet, but simply to see if the procedure itself, recruiting patients, and follow-up appointments can be done smoothly at the Gold Coast University and Princess Alexandra Hospitals. About 25 patients will participate in this initial 'feasibility' study. The results will help doctors decide if it's worth doing a larger study in the future to properly check if this pacemaker upgrade helps improve patients' health and quality of life.
Interventions
The Left Bundle Branch Area Pacing (LBBAP) intervention for this study involves:
What it involves for participants: Participants will undergo a further surgical procedure to upgrade their existing Cardiac Resynchronisation Therapy (CRT) pacemaker system. This involves a specialist heart doctor (electrophysiologist) implanting a new, thin pacing wire (lead, specifically a Medtronic 3830 model) into a precise location in the heart muscle (the interventricular septum, aiming for the left bundle br
The Left Bundle Branch Area Pacing (LBBAP) intervention for this study involves: What it involves for participants: Participants will undergo a further surgical procedure to upgrade their existing Cardiac Resynchronisation Therapy (CRT) pacemaker system. This involves a specialist heart doctor (electrophysiologist) implanting a new, thin pacing wire (lead, specifically a Medtronic 3830 model) into a precise location in the heart muscle (the interventricular septum, aiming for the left bundle branch area). This is done via a vein, typically under the collarbone, using X-ray guidance. The existing wire in the heart's vein (coronary sinus lead) will then be disconnected from the pacemaker device, and the new LBBAP lead will be connected. This is not an external modification; it is an invasive surgical upgrade to their implanted device. Frequency/duration of the intervention: The LBBAP upgrade procedure is a one-time surgical event. While the protocol doesn't specify an exact duration for the surgery itself (it's listed as a procedural success metric to be recorded), such procedures typically last one hour. Once the new lead is implanted and functioning, the LBBAP is continuous. Participants will then be followed up for observation and data collection at scheduled visits (2 months, 6 months, and 12 months post-procedure). Who will be administering the intervention: The LBBAP upgrade procedure will be performed by Staff Specialist Electrophysiologists (cardiologists specializing in heart rhythm disorders) at the participating study hospitals. Standardized or individualized protocol: All participants will undergo the same LBBAP upgrade procedure with the goal of achieving effective pacing from the left bundle branch area. However, the precise final position of the new pacing lead within the heart's septum, and the electrical settings used to confirm optimal LBBAP capture (like sensing, pacing thresholds, and QRS morphology/duration), will be individualized for each participant during the procedure to ensure the best possible physiological pacing based on their specific anatomy and cardiac electrical activity. Monitoring adherence to the intervention: Adherence to the LBBAP intervention (meaning the LBBAP system is implanted and functioning as intended to provide pacing) is monitored through regular device interrogations at follow-up visits. These interrogations allow the study team to check the LBBAP lead's parameters (e.g., stability, electrical measurements) and confirm ongoing effective pacing, thus ensuring the intervention is being delivered as planned.
Sponsors
Princess Alexandra Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with Heart Failure with reduced Ejection Fraction (HFrEF) with existing Cardiac Resynchronisation Therapy (CRT) who are at least 6 months post-implant and are showing signs of CRT non-response. 2. CRT (Defibrillator or Pacemaker) of greater than or equal to 6 months duration 3. New York Heart Association (NYHA) class II-IV symptoms 4. Native QRS width of 150-180ms and Left Bundle Branch Block (LBBB) 5. Greater than or equal to 90% Biventricular (BiV) pacing 6. Ejection Fraction (EF) less than or equal to 35% and improvement from baseline EF less than or equal to 10% post CRT implant after at least 6 months
Exclusion criteria
Cognitive impairment: Defined as diagnosed cognitive disorders such as dementia or other neurodegenerative diseases, or a history of stroke or traumatic brain injury resulting in low scores on cognitive tests like the Mini-Mental State Examination (MMSE) (scores within the range of 19 to 23 inclusive, out of 30) or Montreal Cognitive Assessment (MoCA) (scores within the range of 18 to 25 inclusive, out of 30). Also includes significant functional impairments in daily living due to cognitive deficits from severe psychiatric disorders. Chronic infection: (This is a major contraindication to cardiac device insertion). Metastatic cancer: (This is likely to confound the validity of the primary outcome and is likely to negatively affect wound healing and the safety of the upgrade procedure). Patients with a prognosis of less than 12 months will be excluded given the 12-month enrolment period of the study. Patients with New York Heart Association (NYHA) Class I symptoms will be excluded as they are unlikely to have Cardiac Resynchronisation Therapy (CRT) non-response by definition and cannot see improvement with respect to the primary outcome. Severe Pulmonary hypertension secondary to a non-cardiac condition. Uncontrolled Obstructive Sleep Apnoea secondary to a non-cardiac condition. Severe renal impairment (e.g., estimated Glomerular Filtration Rate (eGFR) less than 30 mL/min/1.73 m²). Advanced Liver Disease (Child-Pugh Score greater than or equal to B7 or Model for End-Stage Liver Disease (MELD) Score greater than or equal to 15). Untreated iron deficiency defined as Serum Ferritin less than 100 ng/mL, or Serum Ferritin between 100-299 ng/mL with Transferrin Saturation (TSAT) less than 20%.
Outcome results
None listed