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

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ClinicalTrials.gov Identifier: NCT03024268
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Philipp Lurz, University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Heart Septal Defects, Atrial Device: Figulla Flex Occluder (Occlutech) Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting
Study Start Date : January 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2021

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)



Primary Outcome Measures :
  1. Change in Exercise tolerance: 6 minute walking test [ Time Frame: baseline, 3 and 6 months ]

Secondary Outcome Measures :
  1. Change in New York Heart Association Functional Classification assessment [ Time Frame: baseline, 3 and 6 months ]
    Changes in New York Heart Association Functional Classification

  2. Changes in Echocardiography: bi ventricular function (2D and 3D) [ Time Frame: baseline, 3 and 6 months ]
  3. Changes in Echocardiography: assessment of left atrium (2D and 3D) [ Time Frame: baseline, 3 and 6 months ]
  4. Changes in Echocardiography: assessment of heart valves [ Time Frame: baseline, 3 and 6 months ]
  5. Changes in Echocardiography: strain using speckle tracking [ Time Frame: baseline, 3 and 6 months ]
  6. Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D) [ Time Frame: baseline, 3 and 6 months ]
  7. Heart insufficiency bio markers [ Time Frame: baseline and 6 months ]
  8. Changes in Cardiac MRI: bi ventricular function [ Time Frame: baseline and 6 months ]
  9. Changes in Cardiac MRI: left ventricular longitudinal strain [ Time Frame: baseline and 6 months ]
  10. Changes in Cardiac MRI: left ventricular circumferential strain [ Time Frame: baseline and 6 months ]
  11. Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta [ Time Frame: baseline and 6 months ]
  12. Evaluation of hospitalisation rate [ Time Frame: baseline, 3, 6 and 12 months ]
    Telephone

  13. Evaluation of mortality [ Time Frame: baseline, 3, 6 and 12 months ]
    Telephone

  14. Combined endpoint (hospitalisation and mortality) [ Time Frame: baseline, 3, 6 and 12 months ]
    Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.

  15. Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire [ Time Frame: baseline and 6 months ]
  16. Changes in quality of life in "Short Form - 36" questionnaire [ Time Frame: baseline and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024268


Contacts
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Contact: Philipp Lurz, MD, PhD +49341865252022 Philipp.Lurz@gmx.de
Contact: Stephan Blazek, MD +49341865252025 stephan.blazek@medizin.uni-leipzig.de

Locations
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Germany
Heart Center of the University Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Philipp Lurz, MD, PhD    +49341865252022    Philipp.Lurz@gmx.de   
Principal Investigator: Philipp Lurz, MD, PhD         
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Philipp Lurz, MD, PhD Heart Center of the University Leipzig
Study Chair: Stephan Blazek, MD Heart Center of the University Leipzig

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Responsible Party: Philipp Lurz, Clinical Investigator M.D. Ph. D. Philipp Lurz, University of Leipzig
ClinicalTrials.gov Identifier: NCT03024268     History of Changes
Other Study ID Numbers: MITHRAS
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Heart Septal Defects
Mitral Valve Insufficiency
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Valve Diseases