At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- percutaneous paravalvular leak closure (procedure)
- How long the study runs
- Study runs about 78 months (dates as stated)
- About the drug or intervention
- percutaneous paravalvular leak closure — procedure: the procedure consists of deployment of an occluder or a vascular plug within the cardiac paravalvular leak.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 16 Years to 110 Years
- Who
- All
- Number of participants
- 400
- Started
- 2020-01-01
- Last checked
- 2022-08
Plain English Summary
What is this study?
- • Testing a new treatment for cardiac valve disease
- • Clinical study - 400 participants
- • Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement
Who can take part?
- • Ages 16 Years to 110 Years
- • Diagnosed with cardiac valve disease
Where?
- • Cambridge - Royal Papworth hospital
- • Edinburgh - Edinburgh Royal Infirmary
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Paraprosthetic cardiac valve leaks are a progressive complication after 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 been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.
More detail
OBJECTIVES OF THE STUDY MAIN OBJECTIVE To evaluate the clinical results of the transcatheter closure of para-prosthetic leaks. SECONDARY OBJECTIVE Technical success of the procedure defined by successful placement of the prosthesis at the intended site with at least a 1 grade reduction in leakage and residual leakage grade 0-1 Change in quality of life after closure of para-prosthetic leakage at 3 months Evolution of clinical and biological markers of hemolysis and heart failure between at 3 months evolution of clinical markers of functional capacity 4. JUDGMENT CRITERIA 4.1 PRIMARY ENDPOINT -Clinical success of the procedure: Clinical success will be assessed on a composite endpoint at 2 years: * vital status, * hospitalization for heart failure, * blood transfusion for hemolysis, * surgical or percutaneous re-intervention on the treated valve. 4.2 SECONDARY ENDPOINTS The technical, echographic, biological and clinical data of the procedure and post procedure will be recorded as well as the complication rates. The EQ5D-5L quality of life score will be evaluated before the procedure, between 1 and 3 months, and post procedure. STUDY POPULATION INCLUSION CRITERIA To be included, each patient must meet all of the following conditions: * Patients aged 16 years and older, * Patients or the representative of the parental authority of the minor patient who does not object to participation in the observatory, * Patients referred for a para-prosthetic leak closure procedure NON-INCLUSION CRITERIA Patients presenting at least one of the following criteria cannot be included * Patients under 16 years of age, * Refusal of the patient or the representative of the parental authority of the minor patient to participate in the observatory.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years - 110 Years
- Who can join: All genders
What the study is looking for
- ✓≥16 years of age No opposition from the patient or the representative of the parental authority if the patient is a...
Who cannot take part
- ✗\< 16 years old Refusal of the patient to participate in the observatory or of the legal representative if the...
See the full criteria
Where Is This Study? (2 UK sites)
Royal Papworth hospital
Cambridge, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
How to Get in Touch
Sebastien Hascoet, MD, PhD
Sponsor contactCONTACT
Benoit Gerardin, MD
Sponsor contactCONTACT
