Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05117359 |
| Other study ID # |
16.622retro |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
January 1, 2020 |
Study information
| Verified date |
October 2021 |
| Source |
Centre Chirurgical Marie Lannelongue |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Despite improvements in available techniques and prostheses, the long-term evolution of
patients after transcatheter paravalvular leak closure remains poorly understood. The
objective of this study is to evaluate the long-term outcome of patients after transcatheter
paravalvular leak closure and to identify factors predictive of survival.
The investigators designed a retrospective multicentre observational registry entitled FFPP
(e.g. "Fermeture des Fuites Para-Prothétiques" in French). Seventeen centres from France,
Poland, Turkey and Belgium enrolled retrospectively at least one PVLc procedure on aortic,
mitral, tricuspid or pulmonary valves without limit in its delay of performance.Follow-up of
at least one year was expected
Description:
Paravalvular leak (PVL) of cardiac valve prostheses is a frequent complication after surgical
valve replacement. The incidence varies according to the type of prosthesis and location,
ranging from 2-15% for aortic prostheses and 7-17% for mitral prostheses, with an increasing
incidence over time. PVL may also be observed after percutaneous valve replacement. After
transcatheter aortic valve implantation (TAVI) the incidence of PVL at 1 year is 6%,
regardless of the type of prosthesis placed.
The majority of these leaks do not lead to symptoms but they are sometimes responsible for
hemolytic anemia, heart failure and infectious endocarditis, thus posing an indication for
closure. The reference technique for PVL closure (PVLc) is redo cardiac surgery despite
significant morbidity and mortality.
Percutaneous PVLc techniques have been developed since 1992. Several small case series have
been published since then, highlighting the different closure techniques and the modalities
for evaluating PVL by 3D ultrasound and CT scan. Several multicenter registries have also
been published that trace current practices and also identify prognostic factors for success
in the short to medium term.
However, despite improvements in available techniques and prostheses, the long-term evolution
of patients after percutaneous PVLc remains poorly understood. The objective of this study is
to evaluate the long-term outcome of patients after percutaneous PVLc and to identify factors
predictive of survival.
The investigators designed a retrospective multicentre observational registry entitled FFPP
(e.g. "Fermeture des Fuites Para-Prothétiques" in French). Seventeen centres from France,
Poland, Turkey and Belgium enrolled retrospectively at least one PVLc procedure on aortic,
mitral, tricuspid or pulmonary valves without limit in its delay of performance.Enrolment
started on January 1st, 2017. Study database was closed on december 31st, 2019. The study was
financially supported by Marie Lannelongue Hospital, without any financial support from the
industry. This research was conducted according to Declaration of Helsinki. The study
protocol was approved by an independent review board (CCTIRS, 6th January 2017, n°16-622). An
electronic case report form was created (easy-crf®). Each local investigator entered data
using a secure access. Data quality control was performed by Marie-Lannelongue research
assistants.
Past medical history, cardiac surgery details, clinical, biological and echocardiographic
parameters were collected. EUROSCORE II risk scale (http://euroscore.org) was assessed with
the assumption that a surgical valve replacement would be performed. Both technical success
and clinical success were defined according to the Paravalvular Leak Academic Research
Consortium. Technical success was implantation of at least one device within the leak, with
an at least 1-grade decrease in the echocardiographic leak-severity grade, no valve
dysfunction, and no surgical conversion of the procedure. Clinical success was survival at
one month without re-admission for heart failure, blood transfusion, or open-heart valvular
surgery. The investigators distinguished per procedural complications, in-hospital
complications (index hospitalization) and complications occurring during follow-up.
Complication's severity was graded using a five levels scale.For each patient, the latest
follow-up data at the time of the inclusion period was collected. Follow-up of at least one
year was expected. New valvular surgery, new PVLc procedure, death and its causes were
collected through the patients themselves or their cardiologist by each local investigator.
