Cardiac ValvesPVL closureNCT03793296
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
A study testing Percutaneous Device Closure: Vascular plug in people with Cardiac Valves and Heart Valve Diseases, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency
- What is being tested?
- Percutaneous Device Closure: Vascular plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jan 2019to 31 Dec 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
- Required treatment of paravalvular leakage due to heart failure or hemolysis
- There is a formal agreement of heart team as following
- predicted high-risk (STS score ≥8 OR Logistic EuroSCORE ≥20% OR operative mortality is ≥15%)
- Inoperable status due to old age or frailty
- Written consent
Who cannot join
- Risk of valve embolization because of valve dehiscence or instability
- Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram), or chest pain/discomfort)
- Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal echocardiographic study
- Life expectancy less than 6 months due to non-cardiac disease
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve replacement_Pilot Study
This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.
- Conditions
- Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency
- Being tested
- Percutaneous Device Closure: Vascular plug
- Keywords
- Paravalvular leak
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Device Closure: Vascular plugDevice
percutaneous transcatheter approach into cardiac valve
| Study group | Role | What they receive |
|---|---|---|
| Paravalvular leak | Experimental | After transcatheter- or surgical valve replacement Receives: Device: Percutaneous Device Closure: Vascular plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of para-valvular leakage
classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2)
Measured: 1 month
Secondary outcomes (10)
Event rate of all cause death
Measured: up to 5 years
Event rate of cardiac death
Measured: up to 5 years
Event rate of stroke
Measured: up to 5 years
Event rate of myocardial infarction
Measured: up to 5 years
Event rate of rehospitalization
Measured: up to 5 years
Event rate of infection
Valve related infection or infective endocarditis
Measured: up to 5 years
Event rate of acute kidney injury
Measured: 1 month
Event rate of vascular complication
Measured: 1 month
Event rate of bleeding
Measured: 1 month
Event rate of device success
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start31 Jan 2019 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: At sponsor's discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ValvesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793296
- Sponsor's protocol ID
- AMCCV2018-11
- Acronym
- PVL closure
- Status last verified
- Jan 2019
- First submitted
- 30 Dec 2018
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve replacement_Pilot Study
- ClinicalTrials.gov ID
- NCT03793296
- Acronym / sponsor ID
- PVL closure / AMCCV2018-11
- Conditions
- Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency
- Keywords
- Paravalvular leak
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: At sponsor's discretion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 31 Jan 2019 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jan 2019 (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.
This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paravalvular leak | Experimental | Device: Percutaneous Device Closure: Vascular plugAfter transcatheter- or surgical valve replacement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
- Required treatment of paravalvular leakage due to heart failure or hemolysis
- There is a formal agreement of heart team as following
- Inoperable status due to old age or frailty
- Written consent
Key exclusion criteria (5 listed)
- Risk of valve embolization because of valve dehiscence or instability
- Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram), or chest pain/discomfort)
- Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal echocardiographic study
- Life expectancy less than 6 months due to non-cardiac disease
- Pregnant or breastfeeding
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 |
|---|---|---|
| Percutaneous Device Closure: Vascular plugpercutaneous transcatheter approach into cardiac valve | Device | Paravalvular leak |
Primary outcome
Degree of para-valvular leakage
Time frame: 1 month
classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2)
10 secondary outcomes
Event rate of all cause death
Time frame: up to 5 years
Event rate of cardiac death
Time frame: up to 5 years
Event rate of stroke
Time frame: up to 5 years
Event rate of myocardial infarction
Time frame: up to 5 years
Event rate of rehospitalization
Time frame: up to 5 years
Event rate of infection
Time frame: up to 5 years
Event rate of acute kidney injury
Time frame: 1 month
Event rate of vascular complication
Time frame: 1 month
Event rate of bleeding
Time frame: 1 month
Event rate of device success
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Valves
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
RecruitingObservational study
Heart Failure and Aortic Stenosis Transcriptome
Heart Failure, Aortic Stenosis
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Device Closure: Vascular plug in people with Cardiac Valves and Heart Valve Diseases, run by Seung-Jung Park at 1 site in South Korea.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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?
Degree of para-valvular leakage (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.