Informations générales (source: ClinicalTrials.gov)
Para-Prosthetic Valve Leak Closure Observatory - PVLC2
Observational [Patient Registry]
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
janvier 2020
juillet 2027
31 octobre 2026
Para-prosthetic heart valve leakage is an evolving complication after surgical or
percutaneous heart valve replacement. These leaks can lead to heart failure and/or
life-threatening hemolysis.
Percutaneous closure of para-prosthetic leaks has developed as an alternative to surgery
in high-risk surgical patients. These procedures remain difficult on the technical side
with a significant risk of failure and complications but have been improving since the
development of dedicated prostheses and the increase in operator experience.
A sharing of experience through the creation of an international expert group has been
initiated since 2017 formalised by biannual expert meetings, the elaboration of
recommendations in progress and the establishment of an international observatory
PVLC1(CCTIRS N°16-62) on 2017-2019.
Beyond the technical aspects and the follow-up of major cardiovascular events collected
in PVLC1, the investigators also wonder what impact these procedures have on the quality
of life of patients. The investigators suggest that even a partial decrease in
para-prosthetic leakage may be associated with an improvement in quality of life by
reducing the need for transfusion and/or reducing dyspnea.
A new PVLC2 study is justified to continue the evolutionary follow-up of the technical
and clinical results of these procedures, accompanied by the evaluation of the possible
benefit on the quality of life of the patients.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL MARIE LANNELONGUE | Sebastien HASCOËT, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
- ≥ 16 years and older
- Non-opposition of the patient or child's legal representative
- Patient referred for a percutaneous para-prosthetic leakage closure procedure
Exclusion Criteria:
- ≤ 16 years of age
- Refusal of the patient to participate in the observatory or the legal representative
if the patient is a minor.