The German Plug - Registry
PLUG
Interventional Therapy of Paravalvular Post-surgical or Post-interventional Valve Replacement Leaks With Plug Devices: The German Plug - Registry
1 other identifier
observational
49
1 country
1
Brief Summary
In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2022
CompletedApril 12, 2023
May 1, 2022
3.1 years
June 6, 2017
April 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
mortality risk
observation of the mortality risk
five years
Interventions
Observational study on patients with paravalvular leak
Eligibility Criteria
200 patients with valve prosthesis defects, with which the indication for plug implantation was placed prospectively and retrospectively, are to be included in the register.
You may qualify if:
- heart valve replacement
- Valve Replacement Leaks
- Plug Device
You may not qualify if:
- no written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Ludwigshafen
Ludwigshafen, Deutschland, 67063, Germany
Related Publications (1)
Konrad H, Werner N, Ouarrak T, Schofer J, Lubos E, Geist V, Eggebrecht H, Butter C, Schmitz T, Schafer U, Schumacher B, Schneider S, Zeymer U, Zahn R. Acute and long-term results of interventional treatment of paravalvular leaks after prosthetic valve replacement with plug devices: results from a prospective multicentre registry. Clin Res Cardiol. 2025 Jun 2. doi: 10.1007/s00392-025-02681-w. Online ahead of print.
PMID: 40455223DERIVED
Study Officials
- STUDY CHAIR
Ralf Zahn, Prof.
Klinikum Ludwigshafen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2017
First Posted
June 7, 2017
Study Start
June 1, 2017
Primary Completion
June 30, 2020
Study Completion
May 25, 2022
Last Updated
April 12, 2023
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share