Status:
COMPLETED
Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL.
Lead Sponsor:
Balton Sp.zo.o.
Collaborating Sponsors:
KCRI
Conditions:
PVL - Paravalvular Leak
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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....
Detailed Description
Transcatheter closure of PVL has emerged as a new treatment strategy that can be offered to patients with isolated PVL or to those with a very high risk of repeat surgery. The transcatheter approach i...
Eligibility Criteria
Inclusion
- The presence of clinically and haemodynamically significant leakage around the surgically implanted cardiac prosthesis in the mitral or aortic position.
- Heart surgery (heart team) disability after another cardiac surgery.
- Technical feasibility of paravalvular leakage closure according to experienced operator.
Exclusion
- Active endocarditis on artificial valve
- Instability of artificial valve
- The amount of cavity that prevents effective closure with an occluder
- A history of acute coronary syndrome in less than 3 months before enrollment
- Confirmed echocardiography of transplatin or transesophageal echocardiography
- Hypersensitivity to contrast media
- Any condition associated with the expected life expectancy of less than 6 months
- Haemorrhagic diathesis
- Significant renal impairment (eGFR \<30 mL/min/1.73m2)/chronic kidney disease at \>G3 stage
- Pregnancy or lactation
- Under 18 years of age
- Patient unable or unwilling to give an informed consent to participate in the study
Key Trial Info
Start Date :
May 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03371472
Start Date
May 8 2017
End Date
July 14 2018
Last Update
January 17 2019
Active Locations (2)
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1
II Oddział Kliniczny Kardiologii i Interwencji Sercowo-Naczyniowych, Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland, 31-501
2
III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
Katowice, Silesian Voivodeship, Poland, 40-635