Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation
| Registry | NCT05895097 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | University Medical Centre Ljubljana (Other) |
| Conditions | Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy, Transcatheter Aortic Valve Implantation |
| Interventions | Left bundle branch pacemaker, Conventional pacing (Device) |
| Dates | start 2023-06-15 (estimated), primary completion 2025-06-15 (estimated), completion 2026-06-15 (estimated), first posted 2023-06-08, last updated 2023-06-08 |
| Locations | 1 site in Slovenia |
Related Papers Related Patents Related Grants Related Experts
All trials for Aortic Valve Stenosis All trials for Heart Failure All trials of Left bundle branch pacemaker All trials of Conventional pacing
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).
Bradycardic heart rhythm disturbances are a common complication of TAVI. Patients who will develop the indication for permanent pacemaker implantation after TAVI will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) group. The investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. The investigators will also compare electrocardiographic (QRS duration), clinical (NYHA status, 6-minute walking test, handgrip test, Kansas City Cardiomyopathy Questionnaire) and laboratory (proBNP) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Conventional pacing | Active comparator | Device: Conventional pacing | |
| LBB pacing | Experimental | Device: Left bundle branch pacemaker |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization) * Left ventricular ejection fraction < 50 %. Exclusion Criteria: * Unsuccessful TAVI procedure with life expectancy < 1 year * Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis) * Severe kidney failure (glomerular filtration rate < 30 ml/min) * Previous permanent pacemaker
| Facility | City | Country | Status |
|---|---|---|---|
| University Medical Centre Ljubljana | Ljubljana | Slovenia |