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RECRUITING
NCT07585799
NA

Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conduction

Sponsor: Óscar Cano Pérez

View on ClinicalTrials.gov

Summary

Intraventricular conduction delay alone or in combination with AV conduction delay is associated with a dyssynchronous activation of the ventricles and may result in LV function impairment. Conduction system pacing can restore physiologic ventricular activation in the presence of intraventricular and atrioventricular conduction delays. Patients with intraventricular conduction delay alone or in combination with AV conduction delay who have a permanent pacemaker indication due to intermittent bradycardia and have predominantly intact AV conduction may benefit from continuous CSP.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-07-29

Completion Date

2029-01-15

Last Updated

2026-05-14

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Pacemaker implant

All patients will receive a ventricular lead in the conduction system (HBP or LBBAP) using conventional implant techniques described elsewhere. The pacemaker device and leads should be implanted according to the physician's manual provided with the devices. Only locally approved Medtronic PM generators with MVP algorithms will be used during the study. Investigators will use the Medtronic Select Secure 3830 lead for CSP. Acceptable LBBAP threshold should be \<2,5V@0,5ms. Other commercially available stylet driven leads may be used as bail-out strategy only when CSP cannot be achieved with the 3830 lead at the implanting physician discretion. During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA). It is strongly encouraged the designation of a single and experienced CSP implanting physician at each center.

Locations (3)

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain