Clinical trials: Paravalvular Leak
Transcatheter Aortic Valve Replacement, Hemodynamic Monitoring
Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for elderly patients with high surgical risks.
- Conditions
- Transcatheter Aortic Valve Replacement, Hemodynamic Monitoring, Aortic Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- APPOSE (NCT04281771)
- Testing
- cardiac MRI
- Where
- Netherlands
- Volunteers
- 92 people
- Sponsor
- Radboud University Medical Center
Paravalvular Leak
Cardiac MRI for Post-TAVR Paravalvular Leak Assessment
The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with…
- Trial name
- Class-CMR (NCT03195114)
- Testing
- Multimodality Imaging and Biomarkers
- Where
- 3 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- University of Pittsburgh
Cardiac Valves, Heart Valve Diseases
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.
- Conditions
- Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency
- Trial name
- PVL closure (NCT03793296)
- Testing
- Percutaneous Device Closure: Vascular plug
- Where
- South Korea
- Sponsor
- Seung-Jung Park
Paravalvular Leak, Transcatheter Valve Replacement
Paravalvular Leak for Transcatheter Valve Replacement
The study objective is to assess the agreement between cMRI PVL grading (based on regurgitant fraction) and TTE PVL grading (based on pressure half-time and the ratio of the jet arc to the circumference of the annulus).
- Trial name
- PVL-TAVR (NCT02079129)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Baylor Research Institute
Mitral Paravalvular Leaks (PVL)
A Novel Technique for Percutaneous Mitral Paravalvular Leak Closure: LBBAP Lead Assisted Ventricular Septal Way
The investigators will perform closure the mitral paravalvular leak in patient with mechanical aortic and mitral valve.
- Trial name
- NCT07129122
- Testing
- Transventricular access
- Where
- Turkey (Türkiye)
- Volunteers
- 1 people
- Sponsor
- Bursa Postgraduate Hospital
Valvular Heart Disease, Valve Disease, Heart
Transcatheter Para-Valvular Leak Closure: An International Prospective Multicentre Registry
Prosthetic paravalvular leaks (PVL) leading to heart failure and/or haemolysis can be treated by interventional cardiology or open-heart surgery.
- Trial name
- FFPP1 (NCT05089136)
- Testing
- transcatheter paravalvular leak closure
- Volunteers
- 213 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
PVL - Paravalvular Leak
Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL.
Paravalvular leak (PVL) is a condition that could be treated surgically or by the transcatheter deployment of the occluder devices (plugs). No PVL-specific occluder device is available on the market.
- Trial name
- VALE (NCT03371472)
- Testing
- Visualisation and measuring of paravalvular leak.
- Where
- 2 sites in Poland
- Volunteers
- 18 people
- Sponsor
- Balton Sp.zo.o.
Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation
Transcatheter Para-Valvular Leak Closures
Despite improvements in available techniques and prostheses, the long-term evolution of patients after transcatheter paravalvular leak closure remains poorly understood.
- Conditions
- Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation, Cardiac Valve Disease, Cardiac Catheterization
- Trial name
- FFPP1 (NCT05117359)
- Testing
- transcatheter paravalvular leak closure
- Volunteers
- 366 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Paravalvular Aortic Regurgitation
PARADIGM: Amplatzer Valvular Plug for PVL Closure
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant…
- Trial name
- PARADIGM (NCT04489823)
- Testing
- AVP III
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Cardiac Valve Disease, Paravalvular Aortic Regurgitation
European Multicentre Registry of Percutaneous Paravalvular Leak Closure
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.
- Conditions
- Cardiac Valve Disease, Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation, Paravalvular Leak
- Trial name
- EuroPVL (NCT05506293)
- Testing
- percutaneous paravalvular leak closure
- Where
- 33 sites in Belgium, Czechia and 10 more
- Volunteers
- 400 people
- Sponsor
- Centre Chirurgical Marie Lannelongue