Clinical trial NCT03371472: Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL.
Official title: Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of Paravalvular Leak (Clinical Trial).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PVL - Paravalvular Leak
Lead sponsor: Balton Sp.zo.o.
Sponsor class: INDUSTRY
Collaborators: name: KCRI
First posted: 2017-12-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In a group of patients with PVL there are defined two arms: one where PVL is located in mitral position (10 patients) and the second one where PVL is located in aortic position (10 patients).
Primary purpose: DEVICE_FEASIBILITY

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. VALE consortium plans to design and validate a new PVL dedicated devices (sizing balloon and occluder) in the context of computer 3D modeling, bench testing, preclinical evaluation and clinical research.

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 involves deployment of occlude devices or coils and adopting either a percutaneous or a transapical approach. Limitation of such approach is the fact that no PVL-dedicated device is available on the market, and either vascular-specific plugs or other types of occluders used commonly for closure of ventricular septal defects or patent ductus arteriosus can be used. Several technical issues can make the procedure challenging.

The primary problem is the localization and track of the canal which can be very difficult to engage and cross with the guidewire. Also the maneuverability of the guide catheter in often enlarged left atrium and the passage of the occluder device through narrow and serpiginous canal between calcified annulus and sewing ring is challenging.

Clearly the limitations of current devices and increasing number of patients with significant PVL warrant the attempts to design and validate new PVL-dedicated devices in the context of computer modeling, bench testing, preclinical evaluation and clinical translation. These devices, as sizing balloon, could significantly simplify and shorten the procedure, decrease the risk of complications and incomplete defect closure as well as optimize cost-effectiveness of the procedure by decreasing number of the occluders.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of subjects with sizing procedure success (efficacy outcome)
timeFrame: During index procedure
measure: Incidence of a combined investigational device safety endpoint (safety outcome)
timeFrame: During index procedure
Secondary outcomes:
measure: Frequency of major undesirable cardiovascular events
timeFrame: 30 days observation
measure: Frequency and severity of hemorrhagic complications
timeFrame: 30 days observation
measure: Size of paravalvular leakage after procedure
timeFrame: During index procedure
measure: Comparison of the size of the paravalvular leakage channel illustrated by a dimensional balloon obtained using 3D-TEE and computerized tomography echocardiography
timeFrame: During index procedure
measure: Total radiation dose.
timeFrame: During index procedure
measure: Total radiation time.
timeFrame: During index procedure
measure: Duration of the dimensional procedure.
timeFrame: During index procedure
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: II Oddział Kliniczny Kardiologii i Interwencji Sercowo-Naczyniowych, Szpital Uniwersytecki w Krakowie
state: Małopolskie
city: Katowice
country: Poland
facility: III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
state: Śląskie
Study officials:
affiliation: III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
name: Wojciech Wojakowski, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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