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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mitral Valve Insufficiency; Heart Septal Defects, Atrial
• Intervention / Treatment: Device: Figulla Flex Occluder (Occlutech)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Heart Center of the University Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: interventional closure of iASD; Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)	Device: Figulla Flex Occluder (Occlutech); Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)
No Intervention: B: no intervention; Best medical supportive care (n=40)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Exercise tolerance: 6 minute walking test	baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in New York Heart Association Functional Classification assessment	Changes in New York Heart Association Functional Classification	baseline, 3 and 6 months
Changes in Echocardiography: bi ventricular function (2D and 3D)		baseline, 3 and 6 months
Changes in Echocardiography: assessment of left atrium (2D and 3D)		baseline, 3 and 6 months
Changes in Echocardiography: assessment of heart valves		baseline, 3 and 6 months
Changes in Echocardiography: strain using speckle tracking		baseline, 3 and 6 months
Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)		baseline, 3 and 6 months
Heart insufficiency bio markers		baseline and 6 months
Changes in Cardiac MRI: bi ventricular function		baseline and 6 months
Changes in Cardiac MRI: left ventricular longitudinal strain		baseline and 6 months
Changes in Cardiac MRI: left ventricular circumferential strain		baseline and 6 months
Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta		baseline and 6 months
Evaluation of hospitalisation rate	Telephone	baseline, 3, 6 and 12 months
Evaluation of mortality	Telephone	baseline, 3, 6 and 12 months
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
Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire		baseline and 6 months
Changes in quality of life in "Short Form - 36" questionnaire		baseline and 6 months

Other Outcome Measures

Outcome Measure	Time Frame
Acute changes in right and left ventricular pressures during interventionell ASD closure	immediately before and immediately after ASD closure

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital
• Investigators: Principal Investigator: Philipp Lurz, MD, PhD, Heart Center of the University Leipzig; Study Chair: Stephan Blazek, MD, Heart Center of the University Leipzig

Publications and helpful links

General Publications

• 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. 2022 Nov 13. doi: 10.1007/s10554-022-02750-5. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Mitral Valve Insufficiency; Heart Septal Defects; Heart Septal Defects, Atrial
• Other Study ID Numbers: MITHRAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided