Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL.

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 8, 2017

Primary Completion Date

June 12, 2018

Study Completion Date

July 14, 2018

Conditions
PVL - Paravalvular Leak
Interventions
DEVICE

Visualisation and measuring of paravalvular leak.

Visualisation and measurements of PVL by investigational sizing ballons made by Balton. The balloon is a modification of diameter and length of existing sizing ballons (AcuMark™, AMPLATZER™, Occlutech®).

Trial Locations (2)

31-501

II Oddział Kliniczny Kardiologii i Interwencji Sercowo-Naczyniowych, Szpital Uniwersytecki w Krakowie, Krakow

40-635

III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca, Katowice

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

KCRI

OTHER

lead

Balton Sp.zo.o.

INDUSTRY

NCT03371472 - Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL. | Biotech Hunter | Biotech Hunter