Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector

NCT03766919 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-04-16

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).

Conditions

Interventions

DEVICE

Implant of the INVICTA lead

The implant or the attempt to implant an INVICTA lead

Sponsors & Collaborators

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Pedro MARQUES, MD · Hospital de Santa Maria - Lisboa - Portugal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2020-03-31
Completion
2021-03-31

Countries

  • France
  • Italy
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

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 NCT03766919 on ClinicalTrials.gov