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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371472
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
KCRI
Information provided by (Responsible Party):
Balton Sp.zo.o.

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.


Condition or disease Intervention/treatment Phase
PVL - Paravalvular Leak Device: Visualisation and measuring of paravalvular leak. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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).
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of Paravalvular Leak (Clinical Trial).
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : June 12, 2018
Actual Study Completion Date : July 14, 2018

Arm Intervention/treatment
VALE - PVL leak sizing balloon - mitral
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.
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®).

VALE - PVL leak sizing balloon - aortic
'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.
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®).




Primary Outcome Measures :
  1. Number of subjects with sizing procedure success (efficacy outcome) [ Time Frame: During index procedure ]
    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.

  2. Incidence of a combined investigational device safety endpoint (safety outcome) [ Time Frame: During index procedure ]

    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.



Secondary Outcome Measures :
  1. Frequency of major undesirable cardiovascular events [ Time Frame: 30 days observation ]
    MACCE defined as: cardiac and non-cardiac death, stroke, TIA, myocardial infarction

  2. Frequency and severity of hemorrhagic complications [ Time Frame: 30 days observation ]
    The hemorrhagic complications rated using BARC scale during 30 days follow up

  3. Size of paravalvular leakage after procedure [ Time Frame: During index procedure ]
    Evaluated in transesophageal echocardiography

  4. Comparison of the size of the paravalvular leakage channel illustrated by a dimensional balloon obtained using 3D-TEE and computerized tomography echocardiography [ Time Frame: During index procedure ]
    Comparison of the measurements by sizing balloon to TEE and CT.

  5. Total radiation dose. [ Time Frame: During index procedure ]
    The amount of total radiation dose during index procedure.

  6. Total radiation time. [ Time Frame: During index procedure ]
    The total radiation time of the index procedure.

  7. Duration of the dimensional procedure. [ Time Frame: During index procedure ]
    The duration of the dimensional procedure during index procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371472


Locations
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Poland
II Oddział Kliniczny Kardiologii i Interwencji Sercowo-Naczyniowych, Szpital Uniwersytecki w Krakowie
Kraków, Małopolskie, Poland, 31-501
III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
Katowice, Śląskie, Poland, 40-635
Sponsors and Collaborators
Balton Sp.zo.o.
KCRI
Investigators
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Principal Investigator: Wojciech Wojakowski, Prof. III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
Publications:
Smolka G., Wojakowski W., Ochała A., Roleder T., Gąsior Z. Diagnosis and percutaneous treatment of paravalvular leaks; Post Kardiol Interw 2011; 7, 1 (23): 56-60

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Responsible Party: Balton Sp.zo.o.
ClinicalTrials.gov Identifier: NCT03371472    
Other Study ID Numbers: Protocol Rev 2.0 (2016-09-26)
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing data policy is currently restricted under grant consortium agreement and pending GDPR implementation in Europe.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No