- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03371472
Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL. (VALE)
Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of Paravalvular Leak (Clinical Trial).
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Małopolskie
-
Kraków, Małopolskie, Poland, 31-501
- II Oddział Kliniczny Kardiologii i Interwencji Sercowo-Naczyniowych, Szpital Uniwersytecki w Krakowie
-
-
Śląskie
-
Katowice, Śląskie, Poland, 40-635
- III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
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®).
|
Other: 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
|
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®).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During index procedure
|
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. |
During index procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of major undesirable cardiovascular events
Time Frame: 30 days observation
|
MACCE defined as: cardiac and non-cardiac death, stroke, TIA, myocardial infarction
|
30 days observation
|
Frequency and severity of hemorrhagic complications
Time Frame: 30 days observation
|
The hemorrhagic complications rated using BARC scale during 30 days follow up
|
30 days observation
|
Size of paravalvular leakage after procedure
Time Frame: During index 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
Time Frame: During index procedure
|
Comparison of the measurements by sizing balloon to TEE and CT.
|
During index procedure
|
Total radiation dose.
Time Frame: During index procedure
|
The amount of total radiation dose during index procedure.
|
During index procedure
|
Total radiation time.
Time Frame: During index procedure
|
The total radiation time of the index procedure.
|
During index procedure
|
Duration of the dimensional procedure.
Time Frame: During index procedure
|
The duration of the dimensional procedure during index procedure.
|
During index procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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 and helpful links
General 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
- Scognamiglio G, Santoro G, Fusco F, Russo MG, Sarubbi B. Percutaneous treatment of multi-valvular paraprosthetic leaks in a "fragile" heart. Int J Cardiol. 2016 Nov 1;222:790-791. doi: 10.1016/j.ijcard.2016.07.283. Epub 2016 Aug 2. No abstract available.
- Murakami T, Fujii H, Sakaguchi M, Takahashi Y, Suehiro Y, Nishimura S, Sakon Y, Yasumizu D, Sohgawa E, Shibata T. Intravascular ultrasound for transcatheter paravalvular leak closure. Gen Thorac Cardiovasc Surg. 2017 Aug;65(8):466-469. doi: 10.1007/s11748-016-0700-x. Epub 2016 Aug 8.
- Giacchi G, Freixa X, Hernandez-Enriquez M, Sanchis L, Azqueta M, Brugaletta S, Martin-Yuste V, Masotti M, Sabate M. Minimally Invasive Transradial Percutaneous Closure of Aortic Paravalvular Leaks: Following the Steps of Percutaneous Coronary Intervention. Can J Cardiol. 2016 Dec;32(12):1575.e17-1575.e19. doi: 10.1016/j.cjca.2016.03.013. Epub 2016 Apr 1.
- Smolka G, Pysz P, Kozlowski M, Jasinski M, Gocol R, Roleder T, Kargul A, Ochala A, Wojakowski W. Transcatheter closure of paravalvular leaks using a paravalvular leak device - a prospective Polish registry. Postepy Kardiol Interwencyjnej. 2016;12(2):128-34. doi: 10.5114/aic.2016.59363. Epub 2016 May 11.
- Cruz-Gonzalez I, Rama-Merchan JC, Calvert PA, Rodriguez-Collado J, Barreiro-Perez M, Martin-Moreiras J, Diego-Nieto A, Hildick-Smith D, Sanchez PL. Percutaneous Closure of Paravalvular Leaks: A Systematic Review. J Interv Cardiol. 2016 Aug;29(4):382-92. doi: 10.1111/joic.12295. Epub 2016 May 31.
- Taramasso M, Maisano F, Pozzoli A, Alfieri O, Meier B, Nietlispach F. Catheter-based treatment of paravalvular leaks. EuroIntervention. 2016 May 17;12 Suppl X:X55-X60. doi: 10.4244/EIJV12SXA11.
- Hilling-Smith R, Chong A, Cox S. Mitral paravalvular leak closure by antegrade percutaneous approach using amplatzer PFO closure device. Catheter Cardiovasc Interv. 2017 Aug 1;90(2):E62-E67. doi: 10.1002/ccd.26417. Epub 2016 Apr 16.
- Abdelghani M, Soliman OI, Schultz C, Vahanian A, Serruys PW. Adjudicating paravalvular leaks of transcatheter aortic valves: a critical appraisal. Eur Heart J. 2016 Sep 7;37(34):2627-44. doi: 10.1093/eurheartj/ehw115. Epub 2016 Apr 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Protocol Rev 2.0 (2016-09-26)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PVL - Paravalvular Leak
-
Occlutech International ABCompletedMitral Paravalvular Leaks (PVL) | Aortic Paravalvular Leaks (PVL)Italy
-
Baylor Research InstituteCompletedParavalvular Leak | Transcatheter Valve ReplacementUnited States
-
University of PittsburghCompletedParavalvular LeakUnited States, Canada
-
Centre Chirurgical Marie LannelongueEasy-CRFRecruitingQuality of Life | Cardiac Valve Disease | Outcomes | Paravalvular Aortic Regurgitation | Paravalvular Mitral Regurgitation | Paravalvular LeakBelgium, France, Poland, United Kingdom, Czechia, Greece, Italy, Latvia, Lithuania, Mexico, Spain, Turkey
-
Marwan Sayed MahmoudUnknownParavalvular Leakage After TAVI
-
Centre Chirurgical Marie LannelongueCompletedCardiac Catheterization | Cardiac Valve Disease | Paravalvular Aortic Regurgitation | Paravalvular Mitral Regurgitation
-
University Hospital, Basel, SwitzerlandCompletedProlonged Air Leak | Postoperative Air LeakSwitzerland
-
Amsterdam UMC, location VUmcActive, not recruitingIntraoperative Awareness | Anastomotic Leak Rectum | Anastomotic Leak Small Intestine | Anastomotic Leak Large IntestineBelgium, Netherlands
-
Freek DaamsSAS InstituteRecruitingAnastomotic Leak | Anastomotic Leak Rectum | Anastomotic Complication | Anastomotic Leak Large IntestineNetherlands
-
National Research Oncology and Transplantology...RecruitingAnastomotic Leak Rectum | Anastomotic Leak Large IntestineKazakhstan
Clinical Trials on Visualisation and measuring of paravalvular leak.
-
Jessa HospitalWit-Gele Kruis Limburg; KLAV; Ferm Thuiszorg; I-mens; Vlaams Patiëntenplatform; Wit-Gele... and other collaboratorsRecruitingType 2 Diabetes | Patient Empowerment | Patient Acceptance of Health Care | Multidisciplinary Communication | EmpowermentBelgium
-
Medical University of ViennaCompleted
-
Diskapi Yildirim Beyazit Education and Research...Active, not recruiting
-
Centre Hospitalier Universitaire, AmiensWithdrawn
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrolling by invitation
-
Zhaoyun ZhangUnknownPituitary TumorChina
-
GlaxoSmithKlineCompletedAlzheimer's DiseaseUnited States, Canada, United Kingdom
-
GlaxoSmithKlineCompletedAlzheimer's DiseaseUnited States, Canada
-
Mednax Center for Research, Education, Quality...Completed
-
Campus Bio-Medico UniversityUnknownAtrial Fibrillation | Stroke, IschemicItaly