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Safety and Electrical Performances of XFINE Leads

NCT03922386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2023-04-06

No results posted yet for this study

Summary

The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.

Conditions

  • Bradycardia

Interventions

DEVICE

XFINE leads

Pacemaker subjects with at least one XFINE passive lead

Sponsors & Collaborators

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Alfredo Bardají, Dr. · Hospital Universitari Joan XXIII, Tarragona, Spain

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2021-03-25
Completion
2021-07-23

Countries

  • France
  • Italy
  • Portugal
  • Spain
  • United Kingdom

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 NCT03922386 on ClinicalTrials.gov