PVL - Paravalvular LeakVALENCT03371472
Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL.
A study testing Visualisation and measuring of paravalvular leak. in people with PVL - Paravalvular Leak, run by Balton Sp.zo.o. at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PVL - Paravalvular Leak
- What is being tested?
- Visualisation and measuring of paravalvular leak.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesPoland
- Study dates
- 8 May 2017to 14 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
2 sites in 1 country.
Poland2 sites
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
II Oddział Kliniczny Kardiologii i Interwencji Sercowo-Naczyniowych, Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 31-501
About this study
Official title: 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.
Read the 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.
- Conditions
- PVL - Paravalvular Leak
- Being tested
- Visualisation and measuring of paravalvular leak.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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®).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Visualisation and measuring of paravalvular leak. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During index procedure
Secondary outcomes (7)
Frequency of major undesirable cardiovascular events
MACCE defined as: cardiac and non-cardiac death, stroke, TIA, myocardial infarction
Measured: 30 days observation
Frequency and severity of hemorrhagic complications
The hemorrhagic complications rated using BARC scale during 30 days follow up
Measured: 30 days observation
Size of paravalvular leakage after procedure
Evaluated in transesophageal echocardiography
Measured: 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.
Measured: During index procedure
Total radiation dose.
The amount of total radiation dose during index procedure.
Measured: During index procedure
Total radiation time.
The total radiation time of the index procedure.
Measured: During index procedure
Duration of the dimensional procedure.
The duration of the dimensional procedure during index procedure.
Measured: During index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start8 May 2017
- Primary completion12 Jun 2018
- Study completion14 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PVL - Paravalvular LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balton Sp.zo.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Responsible party
- Sponsor
- Investigators
- Wojciech Wojakowski, Prof., Principal investigator, III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371472
- Sponsor's protocol ID
- Protocol Rev 2.0 (2016-09-26)
- Acronym
- VALE
- Status last verified
- Jan 2019
- First submitted
- 10 Aug 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing data policy is currently restricted under grant consortium agreement and pending GDPR implementation in Europe.
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.
PubMed 27521562Murakami 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.
PubMed 27501692Giacchi 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.
PubMed 27378589Smolka 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.
PubMed 27279872Cruz-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.
PubMed 27242018Taramasso 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.
PubMed 27174113Hilling-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.
PubMed 27084789Abdelghani 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.
PubMed 27075871
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of Paravalvular Leak (Clinical Trial).
- ClinicalTrials.gov ID
- NCT03371472
- Acronym / sponsor ID
- VALE / Protocol Rev 2.0 (2016-09-26)
- Conditions
- PVL - Paravalvular Leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Balton Sp.zo.o.Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Study start
- 8 May 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 14 Jul 2018 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| VALE - PVL leak sizing balloon - mitral | Other | Device: Visualisation and measuring of paravalvular leak.Placement and inflation of PVL leak sizing balloon for visualisation and measuring of paravalvular leak located in mitral position - Balton developed investigational balloon |
| VALE - PVL leak sizing balloon - aortic | Other | Device: Visualisation and measuring of paravalvular leak.'Placement and inflation of PVL leak sizing balloon for visualisation and measuring of paravalvular leak located in aortic position - Balton developed investigational balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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®). | Device | VALE - PVL leak sizing balloon - aortic, VALE - PVL leak sizing balloon - mitral |
Primary outcome
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.
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.
7 secondary outcomes
Frequency of major undesirable cardiovascular events
Time frame: 30 days observation
Frequency and severity of hemorrhagic complications
Time frame: 30 days observation
Size of paravalvular leakage after procedure
Time frame: 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
Total radiation dose.
Time frame: During index procedure
Total radiation time.
Time frame: During index procedure
Duration of the dimensional procedure.
Time frame: During index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- BackgroundSmolka 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: PubMed 27521562Scognamiglio 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.
- Background: PubMed 27501692Murakami 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.
- Background: PubMed 27378589Giacchi 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.
- Background: PubMed 27279872Smolka 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.
- Background: PubMed 27242018Cruz-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.
- Background: PubMed 27174113Taramasso 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.
- Background: PubMed 27084789Hilling-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.
- Background: PubMed 27075871Abdelghani 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.
- Individual participant dataSharing planned: Undecided. IPD sharing data policy is currently restricted under grant consortium agreement and pending GDPR implementation in Europe.
Related trials for PVL - Paravalvular Leak
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wojciech Wojakowski, Prof. principal investigator
III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visualisation and measuring of paravalvular leak. in people with PVL - Paravalvular Leak, run by Balton Sp.zo.o. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with sizing procedure success (efficacy outcome) (time frame: During index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371472, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.