Clinical trial NCT03024268: MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure
Official title: MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Valve Insufficiency
Heart Septal Defects, Atrial
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Exercise tolerance: 6 minute walking test
timeFrame: baseline, 3 and 6 months
Secondary outcomes:
measure: Change in New York Heart Association Functional Classification assessment
timeFrame: baseline, 3 and 6 months
measure: Changes in Echocardiography: bi ventricular function (2D and 3D)
timeFrame: baseline, 3 and 6 months
measure: Changes in Echocardiography: assessment of left atrium (2D and 3D)
timeFrame: baseline, 3 and 6 months
measure: Changes in Echocardiography: assessment of heart valves
timeFrame: baseline, 3 and 6 months
measure: Changes in Echocardiography: strain using speckle tracking
timeFrame: baseline, 3 and 6 months
measure: Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)
timeFrame: baseline, 3 and 6 months
measure: Heart insufficiency bio markers
timeFrame: baseline and 6 months
measure: Changes in Cardiac MRI: bi ventricular function
timeFrame: baseline and 6 months
measure: Changes in Cardiac MRI: left ventricular longitudinal strain
timeFrame: baseline and 6 months
measure: Changes in Cardiac MRI: left ventricular circumferential strain
timeFrame: baseline and 6 months
measure: Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta
timeFrame: baseline and 6 months
measure: Evaluation of hospitalisation rate
timeFrame: baseline, 3, 6 and 12 months
measure: Evaluation of mortality
timeFrame: baseline, 3, 6 and 12 months
measure: Combined endpoint (hospitalisation and mortality)
timeFrame: baseline, 3, 6 and 12 months
measure: Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire
timeFrame: baseline and 6 months
measure: Changes in quality of life in "Short Form - 36" questionnaire
timeFrame: baseline and 6 months
Other outcomes:
measure: Acute changes in right and left ventricular pressures during interventionell ASD closure
timeFrame: immediately before and immediately after ASD closure
Locations:
city: Leipzig
country: Germany
facility: Heart Center of the University Leipzig
Study officials:
affiliation: Heart Center of the University Leipzig
name: Philipp Lurz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center of the University Leipzig
name: Stephan Blazek, MD
role: STUDY_CHAIR
References:
citation: Blazek S, Unterhuber M, Rommel KP, Kresoja KP, Kister T, Besler C, Fengler K, Rosch S, Daehnert I, Thiele H, Lurz P, von Roeder M. Fate of iatrogenic atrial septal defects following mitral transcatheter edge-to-edge repair - a subanalysis of the MITHRAS trial. Int J Cardiovasc Imaging. 2023 Mar;39(3):519-530. doi: 10.1007/s10554-022-02750-5. Epub 2022 Nov 13.
citation: Lurz P, Unterhuber M, Rommel KP, Kresoja KP, Kister T, Besler C, Fengler K, Sandri M, Daehnert I, Thiele H, Blazek S, von Roeder M. Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Repair and Implications of Interventional Closure. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2685-2694. doi: 10.1016/j.jcin.2021.09.023.