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

Balton

Status: Completed

Conditions: PVL - Paravalvular Leak

Treatments: Device: Visualisation and measuring of paravalvular leak.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03371472

Protocol Rev 2.0 (2016-09-26)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

VALE - PVL leak sizing balloon - mitral

Other group

Description:

Placement and inflation of PVL leak sizing balloon for visualisation and measuring of paravalvular leak located in mitral position - Balton developed investigational balloon

Treatment:

Device: Visualisation and measuring of paravalvular leak.

VALE - PVL leak sizing balloon - aortic

Other group

Description:

'Placement and inflation of PVL leak sizing balloon for visualisation and measuring of paravalvular leak located in aortic position - Balton developed investigational balloon

Treatment:

Device: Visualisation and measuring of paravalvular leak.