NCT07049991 Para-Prosthetic Valve Leak Closure Observatory - PVLC2
| NCT ID | NCT07049991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Hôpital Saint-Joseph |
| Condition | Para-prosthetic Heart |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2022-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-01-01 with a primary completion date of 2022-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * ≥ 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.
Frequently Asked Questions
Who can join the NCT07049991 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Para-prosthetic Heart. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07049991 currently recruiting?
Yes, NCT07049991 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondation Hôpital Saint-Joseph to inquire about joining.
Where is the NCT07049991 trial being conducted?
This trial is being conducted at Le Plessis-Robinson, France.
Who is sponsoring the NCT07049991 clinical trial?
NCT07049991 is sponsored by Fondation Hôpital Saint-Joseph. The trial plans to enroll 300 participants.