Mitral Paravalvular Leaks (PVL)NCT07129122
A Novel Technique for Percutaneous Mitral Paravalvular Leak Closure: LBBAP Lead Assisted Ventricular Septal Way
An observational study of Mitral Paravalvular Leaks (PVL), run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators will perform closure the mitral paravalvular leak in patient with mechanical aortic and mitral valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Paravalvular Leaks (PVL)
- What is being tested?
- Transventricular access
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2025to 2 Aug 2025
- Phase
- Observational
- 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
Study population: Participants with prosthetic mitral valve and paravalvular leakage
Who may be able to join
- Had mitral paravalvüler leak Had mitral and aortic mechanical valve
Who cannot join
- Not suitable for left subclavian access Active infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa
About this study
The investigators will perform closure the mitral paravalvular leak in patient with mechanical aortic and mitral valve.
Read the detailed description
The mitral mitral paravalvular leak closure access are left atrial and transapical in patient with mechanical aortic and mitral valve.
In this case the investigators will use interventricular septal access.
- Conditions
- Mitral Paravalvular Leaks (PVL)
- Being tested
- Transventricular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transventricular accessOther
Transventricular access will perform with LBBAP lead from left subclavian way.
| Study group | Role | What they receive |
|---|---|---|
| Transventricular access | Paravalvular leak Receives: Other: Transventricular access |
What is being measured
The primary outcome is the main question the study is designed to answer.
mitral paravalvüler leak closure sucsess
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start31 Jul 2025
- Primary completion2 Aug 2025
- Study completion2 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Paravalvular Leaks (PVL)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129122
- Sponsor's protocol ID
- Bursa YIEAH Case
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ari H, Tutuncu A, Ari S, Balyimez AD, Bozat T. A Novel Technique for Percutaneous Mitral Paravalvular Leak Closure: LBBAP Lead Assisted Ventricular Septal Way. Catheter Cardiovasc Interv. 2026 May;107(6):1682-1686. doi: 10.1002/ccd.70509. Epub 2026 Feb 18.
PubMed 41709488
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique for Percutaneous Mitral Paravalvular Leak Closure: LBBAP Lead Assisted Ventricular Septal Way
- ClinicalTrials.gov ID
- NCT07129122
- Acronym / sponsor ID
- Bursa YIEAH Case
- Conditions
- Mitral Paravalvular Leaks (PVL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 2 Aug 2025 (actual)
- Study completion
- 2 Aug 2025 (actual)
- First posted
- 19 Aug 2025 (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.
The investigators will perform closure the mitral paravalvular leak in patient with mechanical aortic and mitral valve.
Detailed description
The mitral mitral paravalvular leak closure access are left atrial and transapical in patient with mechanical aortic and mitral valve.
In this case the investigators will use interventricular septal access.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transventricular access | – | Other: Transventricular accessParavalvular leak |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with prosthetic mitral valve and paravalvular leakage
Key inclusion criteria (1 listed)
- Had mitral paravalvüler leak Had mitral and aortic mechanical valve
Key exclusion criteria (1 listed)
- Not suitable for left subclavian access Active infection
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 |
|---|---|---|
| Transventricular accessTransventricular access will perform with LBBAP lead from left subclavian way. | Other | Transventricular access |
Primary outcome
mitral paravalvüler leak closure sucsess
Time frame: 2 day
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 22 Aug 2025.
- Derived from this study: PubMed 41709488Ari H, Tutuncu A, Ari S, Balyimez AD, Bozat T. A Novel Technique for Percutaneous Mitral Paravalvular Leak Closure: LBBAP Lead Assisted Ventricular Septal Way. Catheter Cardiovasc Interv. 2026 May;107(6):1682-1686. doi: 10.1002/ccd.70509. Epub 2026 Feb 18.
- Individual participant dataSharing planned: No
Related trials for Mitral Paravalvular Leaks (PVL)
Enrolling by invitationObservational study
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
Paravalvular Leak
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?
An observational study of Mitral Paravalvular Leaks (PVL), run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 22 Aug 2025. 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 Turkey (Türkiye). 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?
mitral paravalvüler leak closure sucsess (time frame: 2 day). 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 NCT07129122, which also lists 1 linked publication.
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 22 Aug 2025.