Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05089136 |
| Other study ID # |
16.622 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Centre Chirurgical Marie Lannelongue |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Prosthetic paravalvular leaks (PVL) leading to heart failure and/or haemolysis can be treated
by interventional cardiology or open-heart surgery. Predictors of clinical success of
transcatheter closure remains little known and should be identified to help choose between
these two options.Patient selection criteria for the best option are needed. The
investigators aimed to identify predictors of clinical success after transcatheter PVL
closure. Consecutive patients referred to 24 European centres for transcatheter PVL closure
in 2017-2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique,
FFPP) and followed over 2 years
Description:
Prosthetic paravalvular leaks (PVL) are associated with congestive heart failure and
haemolysis, for which the standard treatment is open-heart surgery with the attendant risks
to the patient. Transcatheter closure has emerged as an alternative. Patient selection
criteria for the best option are needed. The investigators aimed to identify predictors of
clinical success after transcatheter PVL closure.
The investigators designed a prospective multicentre observational registry named Fermeture
des Fuites Para-Prothétiques (FFPP, closure of PVLs). In Belgium, France, Poland, and Turkey,
24 centres each enrolled at least 1 patient, between 1 January, 2017 and 31 December, 2019.
All centres included consecutive patients referred for PVL closure.
Patients were selected for transcatheter PVL closure as opposed to first-line surgical PVL
closure if they were at high or prohibitive surgical risk or as an alternative option to
surgery if transcatheter PVLc feasibility was high. Patients were selected by each heart-team
of participating centre according to local practice.
The study was coordinated by the clinical research unit of the Marie Lannelongue Hospital (Le
Plessis-Robinson, France) and was approved by an independent ethics committee (CCTIRS, 23
November 2016, n°16.622bis). It complied with the principles set forth in the Declaration of
Helsinki. Informed and signed consent was obtained in all patients prior to the procedures.
Data collection An electronic case-report form (eCRF, Easy-crf.com) was completed for each
patient. The medical history (notably regarding heart surgery), symptoms, physical findings,
laboratory test results, and echocardiographic parameters were collected. The EUROSCORE II
risk score (http://euroscore.org) was determined, since surgical valve replacement was among
the treatment options. Creatinine clearance below 60 mL/min defined renal failure and below
30 mL/min severe renal failure. Heart failure was defined according to the European Society
of Cardiology as the presence of symptoms (dyspnoea, orthopnoea, asthenia) with physical
signs of heart failure (limb oedema, hepato-jugular reflux, crackles on pulmonary
auscultation) linked to the valvular disease.20 Anaemia was defined as haemoglobin <13 g/dL
in men and <12 g/dL in women and haemolytic anaemia as anaemia with lactic dehydrogenase
elevation and/or schistocytes and/or low haptoglobin, in the absence of other causes of
anaemia.
Definitions of technical and clinical success 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.
Adverse events The investigators recorded intra-procedural adverse events, in-hospital
adverse events (during the index hospitalisation), and adverse events within the first month
after the procedure. Adverse events occurring beyond the first month but during the index
hospitalisation were classified as in-hospital adverse events.
Adverse event severity are graded using a five-level scale. Major adverse events were
potentially life-threatening. Bleeding, haemolytic anaemia, acute kidney injury, vascular
complications, and life-threatening events were defined according to the Paravalvular Leak
Academic Research Consortium.
Prospective follow-up is performed over to year.The end of follow-up is expected on the 31th
of december 2021
