Atrial Septal DefectMitraClipASDNCT02453451
The Effect of the Hole in the Cardiac Septum Developed by the MitraClip Procedure on the Blood Flow Mechanics
A study testing 2D-/3D-TTE, 3D-TEE and Walking Test in people with Atrial Septal Defect, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- 2D-/3D-TTE, 3D-TEE and Walking Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen, Department of Medical Clinic I
Aachen, 52074
Mohammad Almalla
Sebastian Reith, Dr. med.
About this study
Official title: The Effect of the Iatrogenic Atrial Septal Defect After MitraClip Procedure on the Hemodynamic Outcome
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.
Read the detailed description
The percutaneous mitral valve reconstruction (PMVR) using the MitraClip system has become an established therapeutic alternative for patients with symptomatic mitral regurgitation and high operative risk. The MitraClip technology represent a catheter-based non-surgical procedure in which a metal cramp (clip) is transported to the place of the defective mitral valve. At the same time, it occurs also a 3-dimensional transesophageal echocardiogram (3D-TEE) with a transseptal puncture to control this procedure. After removal of the guiding catheter a new atrial septal defect can develop which can close spontaneously after weeks or months.
In this study criteria for a standardized evaluation about the effect of the new ASD on hemodynamic parameters - before and after the MitraClip procedure - shall be validated for the first time. The investigators expect to obtain new findings through the exact analysis of the newly formed ASD for the planning, regulation and follow-up of the mitral insufficiency treatment.
- Conditions
- Atrial Septal Defect
- Being tested
- 2D-/3D-TTE, 3D-TEE, Walking Test, MitraClip procedure
- Keywords
- MitraClip, atrial septal defect, iatrogenic
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D-/3D-TTEOther
Also called 2-/3-dimensional transthoracic echocardiography
recording of 3 cardiac cycles
3D-TEEOther
Also called 3-dimensional transesophageal echocardiogram
with colour-Doppler techniques for recording the ASD and the mitral valve
Walking TestOther
for 6 minutes
MitraClip procedureProcedure or surgery
catheter-based non-surgical procedure in which the atrioventricular valves were stuck together permanently via a clip (during the regular patient care)
| Study group | Role | What they receive |
|---|---|---|
| 2D-/3D-TTE; 3D-TEE, Walking Test | Experimental | 6 months after the MitraClip procedure Receives: Other: 2D-/3D-TTE; Other: 3D-TEE; Other: Walking Test; Procedure: MitraClip procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in hemodynamic parameters such as forward flow reduction through the mitral valve and left-to-right shunt due to the newly formed ASD
Measured: after 6 months
Secondary outcomes (3)
quantitative change from baseline in the mitral regurgitation at 6 months
2D and 3D transthoracic echocardiography (TTE) with colour-Doppler techniques
Measured: after 6 months
quality of life
6 minutes walking test
Measured: after 6 months
change from baseline in the ASD area at 6 months
3D TEE (Transesophageal echocardiogram) by direct en face imaging
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453451
- Sponsor's protocol ID
- 15-016
- Acronym
- MitraClipASD
- Status last verified
- Apr 2016
- First submitted
- 13 May 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Iatrogenic Atrial Septal Defect After MitraClip Procedure on the Hemodynamic Outcome
- ClinicalTrials.gov ID
- NCT02453451
- Acronym / sponsor ID
- MitraClipASD / 15-016
- Conditions
- Atrial Septal Defect
- Keywords
- MitraClip, atrial septal defect, iatrogenic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The percutaneous mitral valve reconstruction (PMVR) using the MitraClip system has become an established therapeutic alternative for patients with symptomatic mitral regurgitation and high operative risk. The MitraClip technology represent a catheter-based non-surgical procedure in which a metal cramp (clip) is transported to the place of the defective mitral valve. At the same time, it occurs also a 3-dimensional transesophageal echocardiogram (3D-TEE) with a transseptal puncture to control this procedure. After removal of the guiding catheter a new atrial septal defect can develop which can close spontaneously after weeks or months.
In this study criteria for a standardized evaluation about the effect of the new ASD on hemodynamic parameters - before and after the MitraClip procedure - shall be validated for the first time. The investigators expect to obtain new findings through the exact analysis of the newly formed ASD for the planning, regulation and follow-up of the mitral insufficiency treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2D-/3D-TTE; 3D-TEE, Walking Test | Experimental | Other: 2D-/3D-TTE, Other: 3D-TEE, Other: Walking Test, Procedure: MitraClip procedure6 months after the MitraClip procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D-/3D-TTEAlso: 2-/3-dimensional transthoracic echocardiographyrecording of 3 cardiac cycles | Other | 2D-/3D-TTE; 3D-TEE, Walking Test |
| 3D-TEEAlso: 3-dimensional transesophageal echocardiogramwith colour-Doppler techniques for recording the ASD and the mitral valve | Other | 2D-/3D-TTE; 3D-TEE, Walking Test |
| Walking Testfor 6 minutes | Other | 2D-/3D-TTE; 3D-TEE, Walking Test |
| MitraClip procedurecatheter-based non-surgical procedure in which the atrioventricular valves were stuck together permanently via a clip (during the regular patient care) | Procedure or surgery | 2D-/3D-TTE; 3D-TEE, Walking Test |
Primary outcome
change in hemodynamic parameters such as forward flow reduction through the mitral valve and left-to-right shunt due to the newly formed ASD
Time frame: after 6 months
3 secondary outcomes
quantitative change from baseline in the mitral regurgitation at 6 months
Time frame: after 6 months
quality of life
Time frame: after 6 months
change from baseline in the ASD area at 6 months
Time frame: after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2D-/3D-TTE, 3D-TEE and Walking Test in people with Atrial Septal Defect, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Almalla (+49 241 80 36771, malmalla@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in hemodynamic parameters such as forward flow reduction through the mitral valve and left-to-right shunt due to the newly formed ASD (time frame: after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.