Ignite Creation Date:
2024-05-06 @ 12:27 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03766919
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2018-10-16
Brief Title:
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
Sponsor:
MicroPort CRM
Organization:
MicroPort CRM
Study Overview
Official Title:
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRIENDS
Brief 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
Detailed Description:
FRIENDS study is a pre-market approval INVICTA leads - devices under investigation - are not CE marked interventional prospective longitudinal international European multicenter single arm study
The devices under investigation the INVICTA defibrillation leads are new quadripolar leads to be used with Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators ICDCRT-D
This clinical study intends to demonstrate safety and electrical performances of the INVICTA leads among the different models active fixation either single coil model 1CR or dual coil model 2CR and passive fixation either single coil model 1CT or dual coil model 2CT leads models The clinical data will be used to support the application to CE marking of INVICTA leads
The primary endpoints will be evaluated at 3 months post-implantation secondary endpoints will be evaluated up to 2 years post-implantation
A maximum number of 224 patients will be enrolled in the study in up to 60 centers in Europe
The follow-up visits are scheduled at hospital discharge at 1 month at 3 months at 6 months at 12 months at 18 months and at 24 months post-implant
The devices under investigation the INVICTA defibrillation leads are new quadripolar leads to be used with Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators ICDCRT-D
This clinical study intends to demonstrate safety and electrical performances of the INVICTA leads among the different models active fixation either single coil model 1CR or dual coil model 2CR and passive fixation either single coil model 1CT or dual coil model 2CT leads models The clinical data will be used to support the application to CE marking of INVICTA leads
The primary endpoints will be evaluated at 3 months post-implantation secondary endpoints will be evaluated up to 2 years post-implantation
A maximum number of 224 patients will be enrolled in the study in up to 60 centers in Europe
The follow-up visits are scheduled at hospital discharge at 1 month at 3 months at 6 months at 12 months at 18 months and at 24 months post-implant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIV-PT-18-08-025366 | OTHER | INFARMED Eudamed code | None |