Clinical trials: Paravalvular Leak
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
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.