Why the study?
Does the Occlutech PVL device improve procedural success compared to off-label devices in patients with hemodynamically significant prosthetic paravalvular leak?
Does the Occlutech PVL device improve procedural success compared to off-label devices in patients with hemodynamically significant prosthetic paravalvular leak?
The specifically designed Occlutech PVL device achieved a 100% procedural success rate for transcatheter paravalvular leak closure, appearing safe and effective compared to off-label devices.
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May support dedicated PVL devices in observational data; leaves open randomized confirmation.
Yildirim et al. (2016) studied this question.
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