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NOT YET RECRUITING
NCT05895097
NA

Conventional Versus Left Bundle Branch Pacing in TAVI

Sponsor: University Medical Centre Ljubljana

View on ClinicalTrials.gov

Summary

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).

Official title: Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-06-15

Completion Date

2026-06-15

Last Updated

2023-06-08

Healthy Volunteers

No

Interventions

DEVICE

Left bundle branch pacemaker

Left bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory.

DEVICE

Conventional pacing

Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %

Locations (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia