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CompletedNCT07129122Updated Aug 22, 2025

A Novel Technique for Percutaneous Mitral Paravalvular Leak Closure: LBBAP Lead Assisted Ventricular Septal Way

An observational study in Mitral Paravalvular Leaks (PVL), sponsored by Bursa Postgraduate Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by Bursa Postgraduate Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Mitral Paravalvular Leaks (PVL)
03

In context

Lead sponsor

Bursa Postgraduate Hospital is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with prosthetic mitral valve and paravalvular leakage

Inclusion criteria

  • Had mitral paravalvüler leak Had mitral and aortic mechanical valve

Exclusion criteria

Exclusion Criteria:

  • Not suitable for left subclavian access Active infection
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • Transventricular access

    Paravalvular leak

    Other: Transventricular access

Interventions

  • OtherTransventricular access

    Transventricular access will perform with LBBAP lead from left subclavian way.

06

What researchers measure

Primary outcomes

  1. mitral paravalvüler leak closure sucsess

    Time frame: 2 day

Other outcomes

  1. mitral paravalvüler leak closure sucsess without complication

    Time frame: 2 day

07

Study locations

1 site
  • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
    Bursa, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07129122
Lead sponsor
Bursa Postgraduate Hospital
Responsible party
Hasan ARI (Professor Doctor, Bursa Postgraduate Hospital) — Principal investigator
First posted
Aug 19, 2025
Start date
Jul 31, 2025
Primary completion
Aug 2, 2025
Completion
Aug 2, 2025
Last update
Aug 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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