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

Mitral Valve Insufficiency Clinical Trial

Official title:

MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03024268
• Other study ID #: MITHRAS
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: Heart Center Leipzig - University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Transcatheter mitral valve repair with the MitraClip system is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. There is evidence that the persistence of a relevant iASD after MitraClip is associated with worse clinical outcomes and increased mortality.

The purpose of this study is to investigate, if the interventional closure of an persistant hemodynamic relevant iASD 30 days after MitraClip implantation, has favorable effects on clinical outcome. Eligible patients, after obtaining written informed consent, are 1:1 randomized either in group A (interventional occlusion of iASD) or group B (best supportive care).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Previous MitraClip implantation

• Persistent relevant iASD 30 days after MitraClip intervention

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

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Atrial
• Mitral Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
Germany	Heart Center of the University Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute changes in right and left ventricular pressures during interventionell ASD closure		immediately before and immediately after ASD closure
Primary	Change in Exercise tolerance: 6 minute walking test		baseline, 3 and 6 months
Secondary	Change in New York Heart Association Functional Classification assessment	Changes in New York Heart Association Functional Classification	baseline, 3 and 6 months
Secondary	Changes in Echocardiography: bi ventricular function (2D and 3D)		baseline, 3 and 6 months
Secondary	Changes in Echocardiography: assessment of left atrium (2D and 3D)		baseline, 3 and 6 months
Secondary	Changes in Echocardiography: assessment of heart valves		baseline, 3 and 6 months
Secondary	Changes in Echocardiography: strain using speckle tracking		baseline, 3 and 6 months
Secondary	Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)		baseline, 3 and 6 months
Secondary	Heart insufficiency bio markers		baseline and 6 months
Secondary	Changes in Cardiac MRI: bi ventricular function		baseline and 6 months
Secondary	Changes in Cardiac MRI: left ventricular longitudinal strain		baseline and 6 months
Secondary	Changes in Cardiac MRI: left ventricular circumferential strain		baseline and 6 months
Secondary	Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta		baseline and 6 months
Secondary	Evaluation of hospitalisation rate	Telephone	baseline, 3, 6 and 12 months
Secondary	Evaluation of mortality	Telephone	baseline, 3, 6 and 12 months
Secondary	Combined endpoint (hospitalisation and mortality)	Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.	baseline, 3, 6 and 12 months
Secondary	Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire		baseline and 6 months
Secondary	Changes in quality of life in "Short Form - 36" questionnaire		baseline and 6 months