NCT02453451

Brief Summary

Patients received a MitraClip procedure because of a leakiness of their mitral valves. During this procedure the atrioventricular valves were stuck together permanently via a clip which leads to a reduction of leakiness. As a result of this procedure a small hole remains at the cardiac septum which is called an atrial septal defect (ASD). In most cases the hole will close after a few weeks or months, but in many other cases not. Until now there is no exact data about the effect of this hole on the filling pressure in the heart or on the blood flow behaviour. So the aim of this study is a precise analysis of the blood flow mechanics during and after the MitraClip procedure to identify criteria to get more informations for a better strategy and regulation of the MitraClip procedure.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

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

First Submitted

Initial submission to the registry

May 13, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1.5 years

First QC Date

May 13, 2015

Last Update Submit

April 5, 2016

Conditions

Atrial Septal Defect

Keywords

MitraClipatrial septal defectiatrogenic

Outcome Measures

Primary Outcomes (1)

  • change in hemodynamic parameters such as forward flow reduction through the mitral valve and left-to-right shunt due to the newly formed ASD

    after 6 months

Secondary Outcomes (3)

  • quantitative change from baseline in the mitral regurgitation at 6 months

    after 6 months

  • quality of life

    after 6 months

  • change from baseline in the ASD area at 6 months

    after 6 months

Study Arms (1)

2D-/3D-TTE; 3D-TEE, Walking Test

EXPERIMENTAL

6 months after the MitraClip procedure

Other: 2D-/3D-TTEOther: 3D-TEEOther: Walking TestProcedure: MitraClip procedure

Interventions

2D-/3D-TTEOTHER

recording of 3 cardiac cycles

Also known as: 2-/3-dimensional transthoracic echocardiography
2D-/3D-TTE; 3D-TEE, Walking Test
3D-TEEOTHER

with colour-Doppler techniques for recording the ASD and the mitral valve

Also known as: 3-dimensional transesophageal echocardiogram
2D-/3D-TTE; 3D-TEE, Walking Test
Walking TestOTHER

for 6 minutes

2D-/3D-TTE; 3D-TEE, Walking Test
MitraClip procedurePROCEDURE

catheter-based non-surgical procedure in which the atrioventricular valves were stuck together permanently via a clip (during the regular patient care)

2D-/3D-TTE; 3D-TEE, Walking Test

Eligibility Criteria

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

You may qualify if:

  • patients in which a percutaneous mitral valve reconstruction via the MitraClip system shall be performed due to severe mitral insufficiency because a conventional surgery would be too stressful for them
  • legal age (≥18 years)
  • written informed consent prior to study participation
  • subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel

You may not qualify if:

  • malignant diseases
  • varicose veins of the esophagus
  • patients with central nervous system dysfunction
  • pregnant and lactating females
  • subject has been committed to an institution by legal or regulatory order
  • dependency or working relationship with the investigator
  • participation in a parallel interventional clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen, Department of Medical Clinic I

Aachen, 52074, Germany

RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mohammad Almalla

CONTACT

+49 241 80 36771malmalla@ukaachen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 25, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

DE(1)