Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
NCT04590144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 446
Last updated 2025-07-24
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)
Conditions
- Ventricular Arrythmia
- Lead
- ICD
- Heart Failure
Interventions
- DEVICE
-
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
- Yes
Timeline & Regulatory
- Start
- 2021-06-04
- Primary Completion
- 2022-03-16
- Completion
- 2024-12-23
Countries
- Austria
- France
- Germany
- Italy
- Netherlands
- Portugal
- Spain
- United Kingdom
Study Locations
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