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MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure

NCT03024268 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-05-10

No results posted yet for this study

Summary

Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.

Conditions

  • Mitral Valve Insufficiency
  • Heart Septal Defects, Atrial

Interventions

DEVICE

Figulla Flex Occluder (Occlutech)

Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)

Sponsors & Collaborators

  • Heart Center Leipzig - University Hospital

    lead OTHER

Principal Investigators

  • Philipp Lurz, MD, PhD · Heart Center of the University Leipzig

  • Stephan Blazek, MD · Heart Center of the University Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-09-30
Completion
2021-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03024268 on ClinicalTrials.gov