The German Plug - Registry

Completed

• Conditions: Heart Valve Replacement

• Registration Number: NCT03179969
• Lead Sponsor: Stiftung Institut fuer Herzinfarktforschung

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-07
• Primary Completion: 2020-06-30
• Status Verified: 2022-05
• Study Completion: 2022-05-25
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• heart valve replacement
• Valve Replacement Leaks
• Plug Device

Exclusion Criteria

• no written consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality risk	five years	observation of the mortality risk

Trial Locations

Locations (1)

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, Deutschland, Germany