Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

Study Overview
=================
Brief Summary
-----------------
The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.

Detailed Description
-----------------
The SAPPHYRE study is an ambispective (retrospective and prospective), non-interventional, multicenter, post-market clinical follow-up study. The study objective is to evaluate the safety and performance of Sophysa's CE marked Polaris® 24 adjustable valve system in the treatment of hydrocephalus by shunting the cerebrospinal fluid. It is expected to recruit 126 patients in two-year. Patients will be followed-up up to 5 years post-procedure.

Official Title
-----------------
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

Conditions
-----------------
Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient implanted with the Polaris® 24 adjustable valve system for the following reasons: Primo implant of a valve shunt-based derivation system, or as a Replacement of another valve -based shunt system, or Endoscopic ventriculostomy (EVT) failure Patient having given his/her informed consent prior to inclusion in this study, as per local regulations Exclusion Criteria: Confirmed or suspected infections along the length of the shunt (meningitis, ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in any part of the body Patient on anticoagulant therapy, or presenting with bleeding diathesis, or with haemorrhagic CSF, as the presence of blood in the system could lead to an obstruction in the system Ventriculo-atrial shunts in patient suffering from congenital cardiopathies or other malformations of the cardio-pulmonary system
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related SAE / complications | Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications | 1 year | 
| Valve replacement | Primary performance outcome will be assessed by the incidence of valve replacements | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events / complications | Long term safety will be assessed by the incidence of all adverse events/complications | Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation | 
| Valve replacement | Incidence of valve replacements | Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation | 
| Implant procedure success | Implant procedure success, defined as no immediate re-intervention post-procedure | 0 day (post-procedure) | 
| Change of clinical status scores | Improvement of the following clinical status scores compared to baseline: the Modified Rankin Scale (for adults and children) and the Lansky Performance Scale (for children < 16 years old only) | One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation | 
| Evolution of Clinical symptoms | Clinical symptoms will be assessed according to a 4-grade scale (excellent, good, unchanged, worsened) | One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation | 
| MRI stability | MRI (1.5Tesla or 3Tesla) stability of the pressure adjustment | One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation | 
| Valve pressure adjustment | If required by patient's condition, the physician will adjust the valve pressure with the adjustment kit provided with the Polaris 24 valve. Physician will evaluate the ease of reading and adjusting of the valve pressure (from easy to difficult) | (if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydrocephalus, Adjustable valve, Polaris 24, Cerebrospinal fluid