Atrioventricular Block, Pacemaker
Conditions
Keywords
Pacemaker, Atrioventricular block, TAVI, LBAP
Brief summary
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients. Conventional right ventricular pacing in these cases often leads to interventricular dyssynchrony, which can impair left ventricular ejection fraction and increase the risk of hospitalization, heart failure, and mortality. Cardiac resynchronization therapy via biventricular pacing is sometimes proposed as a secondary intervention but involves additional surgery. A newer pacing technique-selective left bundle branch area pacing-has been developed to provide physiological ventricular activation by stimulating conduction pathways distal to the lesion, thereby avoiding dyssynchrony. Retrospective studies suggest clinical benefits, but no prospective randomized trial has yet evaluated its efficacy compared to standard pacing. The objective of this study is to conduct the first randomized clinical trial comparing left bundle branch area pacing versus conventional right ventricular pacing in patients requiring pacemaker implantation due to atrioventricular block after TAVI.
Interventions
PROCEDUREPacemaker implantation using left bundle branch area stimulation
Pacemaker implantation using left bundle branch area stimulation
PROCEDURERight ventricular pacemaker implantation
Right ventricular pacemaker implantation
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have undergone TAVI for severe aortic valve disease within the past 3 months * Preserved left ventricular ejection fraction (LVEF ≥ 50%) * Indications for pacemaker implantation according to guidelines, including : * Third-degree atrioventricular (AV) block * Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1 * Alternating left and right bundle branch block * HV interval ≥ 70 ms during electrophysiological study * Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI * Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation * Signed informed consent * Patient affiliated with the national health insurance system
Exclusion criteria
* Left ventricular ejection fraction (LVEF) \< 50% before TAVI * Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis) * Previously implanted pacemaker * Patients under legal guardianship, curatorship, or judicial protection * Participation in another interventional therapeutic clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of cardiovascular deaths | 24 months |
| number of hospitalizations for heart failure | 24 months |
| number of surgical reinterventions | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| success rate of the LBAP technique | 3, 12, and 24 months post-implantation | Verification of ECG effectiveness criteria: for the LBAP group: qR or rsR' appearance and for the RVP group: QS or rS aspect |
| comparison of immediate and long-term complications of the LBAP stimulation | 3, 12, and 24 months post-implantation | Adverse events such as: pneumothorax, infection of equipment, displacement of atrial catheter, lumen haematoma, venous thrombosis, pericardial effusion, reoperation, vascular complication, catheter-specific complications |
| ECG measurements | 3, 12, and 24 months post-implantation | QRS duration (ms) |
| left ventricular function (LVEF) | 3, 12, and 24 months post-implantation | — |
| left ventricular diameter | 3, 12, and 24 months post-implantation | — |
| creatinine levels | 3, 12, and 24 months post-implantation | — |
| GFR in CKD EPI | 3, 12, and 24 months post-implantation | — |
| Comparison of the occurrence of atrial fibrillation and ventricular tachycardia (non-sustained or sustained), based on pacemaker monitoring data. | 3, 12, and 24 months post-implantation | — |
| EQ-5D-5L questionnaire. | Baseline (inclusion), 3, 12, and 24 months post-treatment | — |
| Evaluate the cost-effectiveness of left bundle branch area pacing versus standard therapy in this population using a cost-utility analysis. | 24 months post-implantation | This will be calculated from EQ-5D-5L utility scores. |
Countries
France
Contacts
CONTACTResearch and Innovation Departement of Nantes UH
CONTACTDamien MINOIS, M.D
Outcome results
None listed