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Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector

NCT03279484 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2019-09-17

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped\&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector

Conditions

  • Arrythmia, Implatable Cardioverter Defibrillation, Lead

Interventions

DEVICE

NAVIGO 4LV lead implant

All patients will be attempted to implant or implanted with NAVIGO 4LV lead

Sponsors & Collaborators

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Juan Gabriel Martinez Martinez · Hospital General Universitario Alicante Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2019-12-31
Completion
2022-03-31

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • 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 NCT03279484 on ClinicalTrials.gov