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Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)

NCT05351658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-20

No results posted yet for this study

Summary

Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation. However, TPAFL requires the off-label (non-certificated) use of Pacemaker leads and generators. It is designed a fastening system to ensure the safety and efficacy of the procedure: the KronoSafe System®. The aim of this study is to demonstrate the safety and effectiveness of the KronoSafe System® for temporary pacing in a series of patients receiving TPAFL.

Conditions

  • Arrythmia
  • Bradycardia

Interventions

DEVICE

KronoSafe® System

All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.

Sponsors & Collaborators

  • Universidad Miguel Hernandez de Elche

    collaborator OTHER

  • ICU Medical Technologies S.L.

    lead INDUSTRY

Principal Investigators

  • Raimundo Vicente, MD · Intensive Care Physician at Dr. Balmis University Hospital (Alicante)

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2024-11-18
Completion
2024-12-31

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 NCT05351658 on ClinicalTrials.gov