NCT07129122

Brief Summary

The investigators will perform closure the mitral paravalvular leak in patient with mechanical aortic and mitral valve.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2 days

First QC Date

August 2, 2025

Last Update Submit

August 18, 2025

Conditions

Mitral Paravalvular Leaks (PVL)

Outcome Measures

Primary Outcomes (1)

  • mitral paravalvüler leak closure sucsess

    2 day

Other Outcomes (1)

  • mitral paravalvüler leak closure sucsess without complication

    2 day

Study Arms (1)

Transventricular access

Paravalvular leak

Other: Transventricular access

Interventions

Transventricular accessOTHER

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

Transventricular access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with prosthetic mitral valve and paravalvular leakage

You may qualify if:

  • Had mitral paravalvüler leak Had mitral and aortic mechanical valve

You may not qualify if:

  • Not suitable for left subclavian access Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

August 2, 2025

First Posted

August 19, 2025

Study Start

July 31, 2025

Primary Completion

August 2, 2025

Study Completion

August 2, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)