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
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
- Ventricular Arrythmia
- Lead
- ICD
- Heart Failure
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
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