The German Plug - Registry

NCT ID: NCT03179969

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2022-05-25

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

Detailed Description

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. For a number of years, the catheter-based closure of the defect has been increasingly used by means of the implantation of plug-devices as a new treatment method for patients with a high surgical risk. The existing data on the operation method and safety of the method already used at some centers are promising. In order to demonstrate the clinical routine of patients with an interventional occlusion of a PVL in a timely manner, the Stiftung IHF Ludwigshafen will publish a multicentric register entitled "Deutsches Plug Register" The goal is, among other things, the documentation of patient characteristics, indications, and complications of treated patients.The German Heart Foundation promotes the setting up of the plug register.

In this time, 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.

Conditions

Heart Valve Replacement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

paravalvular leak

Observational study on patients with paravalvular leak

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• heart valve replacement
• Valve Replacement Leaks
• Plug Device

Exclusion Criteria

• no written consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Zahn, Prof.

Role: STUDY_CHAIR

Klinikum Ludwigshafen

Locations

Klinikum Ludwigshafen

Ludwigshafen, Deutschland, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40455223 (View on PubMed)

Other Identifiers

PLUG Registry

Identifier Type: -

Identifier Source: org_study_id