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Mitral Valve Insufficiency
+1

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

Sponsored by Heart Center Leipzig - University Hospital

About this trial

Last updated 4 years ago

Study ID

MITHRAS

Status

Unknown status

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Informed consent

- Previous MitraClip implantation

- Persistent relevant iASD 30 days after MitraClip intervention

No

Exclusion Criteria

- Unsuccessful MitraClip implantation

- No relevant iASD 30 days after MitraClip intervention

- Unstable angina in the previous 4 weeks

- Valvular heart disease (aortic, tricuspid or pulmonary valve) planed for surgery or interventional therapy

- Constrictive pericarditis / restrictive cardiomyopathies

- Pericardial effusion planed for surgery or interventional therapy

- Coagulation disorders

- Malignant disease with a life expectance < 12 months

- Pregnancy

- Participation in another study

- iASD diameter > 38 mm

- Aortic minimum distance of the iASD < 5 mm

- Thrombus in left atrial appendage

- Venous access impossible with a 24 French catheter system

- Presence of an inferior vena cava filter