None listed
Conditions
Brief summary
In patients with permanent AF and HFpEF the beneficial effects of conduction system pacing with left bundle branch area pacing (LBBAP) and AV node ablation remains unclear. In particular, there is a lack of data on invasive haemodynamic profiling, exercise capacity and natriuretic peptide changes in patients who undergo conduction system pacing with AV node ablation compared to medical therapy alone. Therefore the aim of this research project is to conduct a single centre, randomized controlled trial of conduction system pacing with AV node ablation, versus medical therapy, in an AF and HFpEF cohort. We will compare the structural and functional cardiac remodelling changes that occur over time in both groups utilizing exercise haemodynamic measurements.
Interventions
Details of the study will be thoroughly explained in the patient information and consent form (PICF) given to potential participants, and participants will be required to provide consent prior to participating. Participants randomised to the intervention arm will undergo conduction system pacing, followed by atrioventricular (AV) node ablation 4 weeks later. Conduction system pacing will be performed by pacing cardiologists and would typically be around 1 hour in duration under sedation.
Con
Details of the study will be thoroughly explained in the patient information and consent form (PICF) given to potential participants, and participants will be required to provide consent prior to participating. Participants randomised to the intervention arm will undergo conduction system pacing, followed by atrioventricular (AV) node ablation 4 weeks later. Conduction system pacing will be performed by pacing cardiologists and would typically be around 1 hour in duration under sedation. Conduction system pacing in this study will be based on left bundle branch area pacing (LBBAP). For this study only the lumenless lead (Medtronic 3830 lead) will be utilized. In brief, the LBBAP lead is positioned on the RV septum within a guiding sheath. Determination of a suitable catheter position is based on anyone of the following techniques: a) Detection of a His potential and advancing the sheath 15–20 mm towards the RV apex in RAO 30 view ; b) Use the tricuspid valve summit as an anatomical marker (which approximates His bundle position), and advancing the sheath 15–20 mm towards the RV apex in RAO 30 view ; c) Divide the septum into 9 sectors in RAO 30 view and targeting the mid section Once the catheter is in position, the LBBAP lead is exposed in contact with the right side of the septum and connected in a unipolar configuration to the PSA recording. A suitable site for lead penetration is based on the demonstration of a ‘W’ pattern on the paced QRS morphology in V1, along with discordant paced QRS morphologies in leads II and III. The lead is subsequent screwed into the septum with rapid continuous rotations. Lead depth during rotations can be determined by one/more of the following techniques a) Fluoroscopy in LAO 30–40° view ; b) Paced QRS morphology in unipolar mode - as the lead progresses from the right side to the left side of the septum, the QRS becomes narrower, terminal R wave appears in V1, and the V6RWPT progressively shortens ; c) Premature ventricular complexes provoked by mechanical trauma ; d) Lead impedance - this usually rises initially and then falls as the lead approaches the LV endocardium; e) Myocardial current of injury (COI) -the COI rises initially but decreases as the lead reaches the LV subendocardial area to an average of approximately 10–12 mV LBB capture is confirmed by the presence of one/more of the following parameters: a) Left ventricular activation time (LVAT) of 44 ms ; d) Left bundle branch potential-V6RWPT interval = pacing stimulus-V6RWPT interval (+/-10ms) AV node ablation will be done by electrophysiologists, which is done with non -irrigated ablation catheters at 50W power setting. The AV node ablation would typically be around 30 minutes in duration and done under sedation. The procedures will be done in person at the time of procedure. All participants in the intervention arm will be followed up for 12 months.. All participants will undergo clinical reviews at 3 months, 6 months and 12 months.
Sponsors
The Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with HFpEF based on the 2021 European Society Cardiology(ESC) guidelines • Symptoms and signs of heart failure • Preserved left ventricular ejection fraction (LVEF greater than or equal to 50%); and • Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides 2. Patients aged equal or more than 18 years old 3. Patients with permanent AF who are not deemed suitable candidate for an AF ablation procedure 4. Patients must be able and willing to provide written informed consent to participate in this investigation 5. Patients must be willing and able to comply with all peri-ablation and follow- up requirements
Exclusion criteria
1. Patients for whom rhythm control will be attempted/pursued 2. Patients with AF felt to be secondary to an obvious reversible cause 3. Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor 4. Pregnancy 5. Ejection fraction of <50% on echocardiogram 6. Severe, non-revascularised coronary artery disease (percutaneous coronary intervention permissible) 7. Severe pulmonary disease 8. Severe valvular heart disease or cyanotic congenital heart disease 9. Severe frailty (Clinical Frailty Scale greater than or equal to 7 or comorbidity reducing life expectancy to 40) 15. Patient inability to consent
Outcome results
None listed