Clinical trials: Paravalvular Aortic Regurgitation
Aortic Valve Insufficiency, Heart Valve Diseases
Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab
Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to…
- Conditions
- Aortic Valve Insufficiency, Heart Valve Diseases, Regurgitation, Aortic, Paravalvular Aortic Regurgitation
- Trial name
- OVAL (NCT04047082)
- Testing
- Quantitative aortogram (videodensitometry)
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Imperial College London
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 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
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
Aortic Stenosis
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation…
- Trial name
- NCT06891079
- Testing
- Videodensitometric guided, Stand of care guided
- Where
- 2 sites in China
- Volunteers
- 320 people
- Sponsor
- Xijing Hospital
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
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
Aortic Valve Stenosis, Aortic Valve Insufficiency
Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes
Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality.
- Trial name
- WITAVI-REAL (NCT03728049)
- Testing
- CT-ADP performed during TAVI procedure, No CT-ADP performed during TAVI procedure
- Where
- 9 sites in France
- Volunteers
- 944 people
- Sponsor
- University Hospital, Lille