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Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy

NCT06474819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2024-07-15

No results posted yet for this study

Summary

Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.

Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.

Conditions

  • Complete Heart Block
  • Second Degree Atrioventricular Block Möbitz Type II

Interventions

DEVICE

Pacemaker implant

All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead.

Sponsors & Collaborators

  • Fundació La Marató de TV3

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    collaborator OTHER

  • Institut d'Investigació Biomèdica de Bellvitge

    lead OTHER

Principal Investigators

  • Andrea Di Marco, MD, PhD · IDIBELL and Hospital Universitario de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2027-01-12
Completion
2027-01-12
FDA Device
Yes

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 NCT06474819 on ClinicalTrials.gov