NCT03024268

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

4.7 years

First QC Date

December 29, 2016

Last Update Submit

May 6, 2021

Conditions

Mitral Valve InsufficiencyHeart Septal Defects, Atrial

Outcome Measures

Primary Outcomes (1)

  • Change in Exercise tolerance: 6 minute walking test

    baseline, 3 and 6 months

Secondary Outcomes (16)

  • Change in New York Heart Association Functional Classification assessment

    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

  • +11 more secondary outcomes

Other Outcomes (1)

  • Acute changes in right and left ventricular pressures during interventionell ASD closure

    immediately before and immediately after ASD closure

Study Arms (2)

A: interventional closure of iASD

EXPERIMENTAL

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

Device: Figulla Flex Occluder (Occlutech)

B: no intervention

NO INTERVENTION

Best medical supportive care (n=40)

Interventions

Figulla Flex Occluder (Occlutech)DEVICE

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

A: interventional closure of iASD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Previous MitraClip implantation
  • Persistent relevant iASD 30 days after MitraClip intervention

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center of the University Leipzig

Leipzig, 04289, Germany

Location

Related Publications (2)

  • 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.

    PMID: 36371488DERIVED

  • 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.

    PMID: 34949392DERIVED

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Philipp Lurz, MD, PhD

    Heart Center of the University Leipzig

    PRINCIPAL INVESTIGATOR

  • Stephan Blazek, MD

    Heart Center of the University Leipzig

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator, Professor, Managing Senior Physician

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 18, 2017

Study Start

January 1, 2016

Primary Completion

September 1, 2020

Study Completion

December 1, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Locations

DE(1)