A Novel Technique for Percutaneous Mitral Paravalvular Le... | NCT07129122

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

NCT07129122

Sponsor

Bursa Postgraduate Hospital

Status

Completed

Last Update Posted

Aug 22, 2025Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Mitral Paravalvular Leaks (PVL)

Interventions

Transventricular access

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2025Actual

Primary Completion Date

Aug 2, 2025Actual

Completion Date

Aug 2, 2025Actual

First Submitted Date

Aug 2, 2025

First Submission Date that Met QC Criteria

Aug 11, 2025

First Posted Date

Aug 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2025

Last Update Posted Date

Aug 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transventricular access		Paravalvular leak	Other: Transventricular access

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transventricular access	Other	Transventricular access will perform with LBBAP lead from left subclavian way.	Transventricular access

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mitral paravalvüler leak closure sucsess		2 day

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
mitral paravalvüler leak closure sucsess without complication		2 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Had mitral paravalvüler leak Had mitral and aortic mechanical valve

Exclusion Criteria:

Not suitable for left subclavian access Active infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants with prosthetic mitral valve and paravalvular leakage

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi		Bursa			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41709488	Derived	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.