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

Primary Purpose

Mitral Valve Insufficiency, Heart Septal Defects, Atrial

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Figulla Flex Occluder (Occlutech)
Sponsored by
Heart Center Leipzig - University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center of the University Leipzig

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A: interventional closure of iASD

B: no intervention

Arm Description

Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)

Best medical supportive care (n=40)

Outcomes

Primary Outcome Measures

Change in Exercise tolerance: 6 minute walking test

Secondary Outcome Measures

Change in New York Heart Association Functional Classification assessment
Changes in New York Heart Association Functional Classification
Changes in Echocardiography: bi ventricular function (2D and 3D)
Changes in Echocardiography: assessment of left atrium (2D and 3D)
Changes in Echocardiography: assessment of heart valves
Changes in Echocardiography: strain using speckle tracking
Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)
Heart insufficiency bio markers
Changes in Cardiac MRI: bi ventricular function
Changes in Cardiac MRI: left ventricular longitudinal strain
Changes in Cardiac MRI: left ventricular circumferential strain
Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta
Evaluation of hospitalisation rate
Telephone
Evaluation of mortality
Telephone
Combined endpoint (hospitalisation and mortality)
Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.
Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire
Changes in quality of life in "Short Form - 36" questionnaire

Full Information

First Posted
December 29, 2016
Last Updated
May 6, 2021
Sponsor
Heart Center Leipzig - University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03024268
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart Center Leipzig - University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Heart Septal Defects, Atrial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: interventional closure of iASD
Arm Type
Experimental
Arm Description
Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)
Arm Title
B: no intervention
Arm Type
No Intervention
Arm Description
Best medical supportive care (n=40)
Intervention Type
Device
Intervention Name(s)
Figulla Flex Occluder (Occlutech)
Intervention Description
Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)
Primary Outcome Measure Information:
Title
Change in Exercise tolerance: 6 minute walking test
Time Frame
baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Change in New York Heart Association Functional Classification assessment
Description
Changes in New York Heart Association Functional Classification
Time Frame
baseline, 3 and 6 months
Title
Changes in Echocardiography: bi ventricular function (2D and 3D)
Time Frame
baseline, 3 and 6 months
Title
Changes in Echocardiography: assessment of left atrium (2D and 3D)
Time Frame
baseline, 3 and 6 months
Title
Changes in Echocardiography: assessment of heart valves
Time Frame
baseline, 3 and 6 months
Title
Changes in Echocardiography: strain using speckle tracking
Time Frame
baseline, 3 and 6 months
Title
Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)
Time Frame
baseline, 3 and 6 months
Title
Heart insufficiency bio markers
Time Frame
baseline and 6 months
Title
Changes in Cardiac MRI: bi ventricular function
Time Frame
baseline and 6 months
Title
Changes in Cardiac MRI: left ventricular longitudinal strain
Time Frame
baseline and 6 months
Title
Changes in Cardiac MRI: left ventricular circumferential strain
Time Frame
baseline and 6 months
Title
Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta
Time Frame
baseline and 6 months
Title
Evaluation of hospitalisation rate
Description
Telephone
Time Frame
baseline, 3, 6 and 12 months
Title
Evaluation of mortality
Description
Telephone
Time Frame
baseline, 3, 6 and 12 months
Title
Combined endpoint (hospitalisation and mortality)
Description
Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.
Time Frame
baseline, 3, 6 and 12 months
Title
Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire
Time Frame
baseline and 6 months
Title
Changes in quality of life in "Short Form - 36" questionnaire
Time Frame
baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Acute changes in right and left ventricular pressures during interventionell ASD closure
Time Frame
immediately before and immediately after ASD closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Lurz, MD, PhD
Organizational Affiliation
Heart Center of the University Leipzig
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Blazek, MD
Organizational Affiliation
Heart Center of the University Leipzig
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center of the University Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36371488
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.
Results Reference
derived
PubMed Identifier
34949392
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.
Results Reference
derived

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

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