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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of Paravalvular Leak (Clinical Trial).

Conditions
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PVL - Paravalvular Leak

Intervention / Treatment
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* Device: Visualisation and measuring of paravalvular leak.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VALE - PVL leak sizing balloon - mitral<br>Placement and inflation of PVL leak sizing balloon for visualisation and measuring of paravalvular leak located in mitral position - Balton developed investigational balloon | Device: Visualisation and measuring of paravalvular leak.<br>* 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®).<br>|
| Other: VALE - PVL leak sizing balloon - aortic<br>'Placement and inflation of PVL leak sizing balloon for visualisation and measuring of paravalvular leak located in aortic position - Balton developed investigational balloon | Device: Visualisation and measuring of paravalvular leak.<br>* 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®).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with sizing procedure success (efficacy outcome) | Sizing procedure is defined as effective when all following steps: device introduction into the leakage channel, filling in the leakage channel, obtaining a balloon image in the X-ray recording and removal of the balloon without complications are performed. | During index procedure | 
| Incidence of a combined investigational device safety endpoint (safety outcome) | Safety of the investigational device defined as the occurrence/frequency of locking, fragmentation of the dimensioning balloon, enlargement of the leakage channel, locking of the mechanical prosthesis disks. Failure to use the investigational device defined as: locking of the dimensional balloon in site, fragmentation of the dimensional balloon, enlargement of the leakage channel dimension directly related to the application of the dimensional balloon, locking of the mechanical prosthesis disks. The failure will be assessed per investigational device and accounted for if at least one of four described events occur. Moreover, the frequency of each event will be additionally assessed and presented in per investigational device analysis. | During index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of major undesirable cardiovascular events | MACCE defined as: cardiac and non-cardiac death, stroke, TIA, myocardial infarction | 30 days observation | 
| Frequency and severity of hemorrhagic complications | The hemorrhagic complications rated using BARC scale during 30 days follow up | 30 days observation | 
| Size of paravalvular leakage after procedure | Evaluated in transesophageal echocardiography | During index procedure | 
| Comparison of the size of the paravalvular leakage channel illustrated by a dimensional balloon obtained using 3D-TEE and computerized tomography echocardiography | Comparison of the measurements by sizing balloon to TEE and CT. | During index procedure | 
| Total radiation dose. | The amount of total radiation dose during index procedure. | During index procedure | 
| Total radiation time. | The total radiation time of the index procedure. | During index procedure | 
| Duration of the dimensional procedure. | The duration of the dimensional procedure during index procedure. | During index procedure |