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

NCT07585799 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Bradycardia

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.

Sponsors & Collaborators

  • Óscar Cano Pérez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-29
Primary Completion
2028-01-15
Completion
2029-01-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585799 on ClinicalTrials.gov