The German Plug - Registry

Heart Valve Replacement Clinical Trial

— PLUG  

Official title:

Interventional Therapy of Paravalvular Post-surgical or Post-interventional Valve Replacement Leaks With Plug Devices: The German Plug - Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179969
• Other study ID #: PLUG Registry
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: May 25, 2022

Study information

• Verified date: May 2022
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 25, 2022
• Est. primary completion date: June 30, 2020
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• heart valve replacement

• Valve Replacement Leaks

• Plug Device

Exclusion Criteria:

• no written consent

Related Conditions & MeSH terms

• Heart Valve Replacement

Intervention

Other:
• paravalvular leak
Observational study on patients with paravalvular leak

Locations

Country	Name	City	State
Germany	Klinikum Ludwigshafen	Ludwigshafen	Deutschland

Sponsors (1)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality risk	observation of the mortality risk	five years