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

NCT03371472 | Completed DMC

• 1 other identifier: Protocol Rev 2.0 (2016-09-26)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

PVL - Paravalvular Leak

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Frequency of major undesirable cardiovascular events

  30 days observation

• Frequency and severity of hemorrhagic complications

  30 days observation

• Size of paravalvular leakage after procedure

  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

  During index procedure

• Total radiation dose.

  During index procedure

Study Arms (2)

VALE - PVL leak sizing balloon - mitral

OTHER

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.

VALE - PVL leak sizing balloon - aortic

OTHER

'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.

Interventions

Visualisation and measuring of paravalvular leak. DEVICE

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; VALE - PVL leak sizing balloon - mitral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Balton Sp.zo.o.: lead
• KCRI: collaborator

Study Sites (2)

II Oddział Kliniczny Kardiologii i Interwencji Sercowo-Naczyniowych, Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca

Katowice, Silesian Voivodeship, 40-635, Poland

Location

Related Publications (9)

• 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

  BACKGROUND

• 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.

  PMID: 27521562 BACKGROUND

• 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.

  PMID: 27501692 BACKGROUND

• 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.

  PMID: 27378589 BACKGROUND

• 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.

  PMID: 27279872 BACKGROUND

• 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.

  PMID: 27242018 BACKGROUND

• 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.

  PMID: 27174113 BACKGROUND

• 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.

  PMID: 27084789 BACKGROUND

• 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.

  PMID: 27075871 BACKGROUND

Study Officials

• Wojciech Wojakowski, Prof.

  III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: December 13, 2017
• Study Start: May 8, 2017
• Primary Completion: June 12, 2018
• Study Completion: July 14, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Locations

PL (2)