Para-prosthetic HeartFFPP2NCT07049991
Para-Prosthetic Valve Leak Closure Observatory - PVLC2
An observational study of Para-prosthetic Heart, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Para-prosthetic Heart
- What is being tested?
- surgical or percutaneous heart valve replacement.
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jul 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients adressed for a paravalvular leak closure.
Who may be able to join
- ≥ 16 years and older
- Non-opposition of the patient or child's legal representative
- Patient referred for a percutaneous para-prosthetic leakage closure procedure
Who cannot join
- ≤ 16 years of age
- Refusal of the patient to participate in the observatory or the legal representative if the patient is a minor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Marie Lannelongue Hospital
Le Plessis-Robinson, 92350
Sebastien HASCOËT, MD, 01.40.94.24.29, s.hascoet@ghpsj.fr
About this study
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.
Read more
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.
- Conditions
- Para-prosthetic Heart
- Being tested
- surgical or percutaneous heart valve replacement.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical or percutaneous heart valve replacement.Procedure or surgery
para-prosthetic heart valve leakage after after surgical or percutaneous heart valve replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the technical and clinical results of the closure of para-prosthetic leaks by assessing the clinical success of the procedure
Clinical success of the procedure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jan 2020
- Primary completion1 Jan 2022
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Para-prosthetic HeartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049991
- Sponsor's protocol ID
- 2019-A02930-57
- Acronym
- FFPP2
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Para-Prosthetic Valve Leak Closure Observatory - PVLC2
- ClinicalTrials.gov ID
- NCT07049991
- Acronym / sponsor ID
- FFPP2 / 2019-A02930-57
- Conditions
- Para-prosthetic Heart
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients adressed for a paravalvular leak closure.
Key inclusion criteria (3 listed)
- ≥ 16 years and older
- Non-opposition of the patient or child's legal representative
- Patient referred for a percutaneous para-prosthetic leakage closure procedure
Key exclusion criteria (2 listed)
- ≤ 16 years of age
- Refusal of the patient to participate in the observatory or the legal representative if the patient is a minor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical or percutaneous heart valve replacement.para-prosthetic heart valve leakage after after surgical or percutaneous heart valve replacement | Procedure or surgery | – |
Primary outcome
Evaluate the technical and clinical results of the closure of para-prosthetic leaks by assessing the clinical success of the procedure
Time frame: 2 years
Clinical success of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Para-prosthetic Heart, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the technical and clinical results of the closure of para-prosthetic leaks by assessing the clinical success of the procedure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.