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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBAP : Left Bundle Area Pacing | Experimental | Pacemaker implantation using left bundle branch area stimulation |
|
| RVP : Right Ventricular Pacing | Placebo Comparator | Right ventricular pacemaker implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker implantation using left bundle branch area stimulation | Procedure | Pacemaker implantation using left bundle branch area stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of cardiovascular deaths | 24 months | |
| number of hospitalizations for heart failure | 24 months | |
| number of surgical reinterventions | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of the LBAP technique | Verification of ECG effectiveness criteria: for the LBAP group: qR or rsR' appearance and for the RVP group: QS or rS aspect | 3, 12, and 24 months post-implantation |
| comparison of immediate and long-term complications of the LBAP stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research and Innovation Departement of Nantes UH | Contact | +33253482810 | bp-prom-regl@chu-nantes.fr | |
| Damien MINOIS, M.D | Contact | +33244768742 | damien.minois@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest University Hospital | Recruiting | Brest | Finistère | 29200 | France |
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| Right ventricular pacemaker implantation | Procedure | Right ventricular pacemaker 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 |
| 3, 12, and 24 months post-implantation |
| ECG measurements | QRS duration (ms) | 3, 12, and 24 months post-implantation |
| 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. | This will be calculated from EQ-5D-5L utility scores. | 24 months post-implantation |
| Rennes University Hospital | Recruiting | Rennes | Ille-et-Vilaine | 35033 | France |
|
| Tours University Hospital | Recruiting | Tours | Indre-et-Loire | 37044 | France |
|
| Nantes University Hospital | Recruiting | Nantes | Loire-Atlantique | 44093 | France |
|
| Clermont Ferrand University Hospital | Not yet recruiting | Clermont-Ferrand | Puy-de-Dôme | 63003 | France |
|
| Rouen University Hospital | Recruiting | Rouen | Seine-Maritime | 76031 | France |
|
| Poitiers University Hospital | Recruiting | Poitiers | Vienne | 86021 | France |
|
| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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