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Clinical Trials/NCT03179969
NCT03179969
Completed
N/A

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

Stiftung Institut fuer Herzinfarktforschung1 site in 1 country49 target enrollmentJune 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Valve Replacement
Sponsor
Stiftung Institut fuer Herzinfarktforschung
Enrollment
49
Locations
1
Primary Endpoint
mortality risk
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
May 25, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Stiftung Institut fuer Herzinfarktforschung
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • heart valve replacement
  • Valve Replacement Leaks
  • Plug Device

Exclusion Criteria

  • no written consent

Outcomes

Primary Outcomes

mortality risk

Time Frame: five years

observation of the mortality risk

Study Sites (1)

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