Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography3D_TTE_TAVINCT01966146
Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI
A study testing Echography GE Healthcare Vivid E9 in people with Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography and Aortic Stenosis, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography, Aortic Stenosis, Mitral Valve Insufficiency
- What is being tested?
- Echography GE Healthcare Vivid E9
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to Oct 2014
- 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 with severe symptoms of an aortic stenosis who underwent catheter based implantation of an aortic valve
- patients who are planned to undergo a reconstruction of the mitral valve with the MitraClip System
- Patients who are aged above 18 years and legally competent
- signed informed consent
Who cannot join
- patients with previous myocard infarction, previous heart surgeries, malignity or valvular abnormities > stage 1
- patients with atrial fibrillation
- pregnant and breast-feeding women
- patients with disturbed central nerve system
- patients with pacemaker, implants, ferrous clamps,insulin pump
- patients with tattoo
- patients with claustrophobia
- patiens with asthma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.
Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.
Read the detailed description
Echocardiography: GE Healthcare Vivid E9
- Conditions
- Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography, Aortic Stenosis, Mitral Valve Insufficiency
- Being tested
- Echography GE Healthcare Vivid E9
- Medical subject headings
- Aortic Valve Stenosis, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echography GE Healthcare Vivid E9Device
Echography GE Healthcare Vivid E9
| Study group | Role | What they receive |
|---|---|---|
| TAVI | Experimental | Echocardiography after TAVI Receives: Device: Echography GE Healthcare Vivid E9 |
| MitraClip | Experimental | Echocardiography after MitraClip procedure Receives: Device: Echography GE Healthcare Vivid E9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures
Measured: Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development of Standardized Assessment TAVI and MitraClip Procedures by EchocardiographyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT01966146
- Sponsor's protocol ID
- 12-067
- Acronym
- 3D_TTE_TAVI
- Status last verified
- Dec 2014
- First submitted
- 17 Jul 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.
- ClinicalTrials.gov ID
- NCT01966146
- Acronym / sponsor ID
- 3D_TTE_TAVI / 12-067
- Conditions
- Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography, Aortic Stenosis, Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Oct 2013 (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.
Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.
Detailed description
Echocardiography: GE Healthcare Vivid E9
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI | Experimental | Device: Echography GE Healthcare Vivid E9Echocardiography after TAVI |
| MitraClip | Experimental | Device: Echography GE Healthcare Vivid E9Echocardiography after 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 with severe symptoms of an aortic stenosis who underwent catheter based implantation of an aortic valve
- patients who are planned to undergo a reconstruction of the mitral valve with the MitraClip System
- Patients who are aged above 18 years and legally competent
- signed informed consent
Key exclusion criteria (8 listed)
- patients with previous myocard infarction, previous heart surgeries, malignity or valvular abnormities > stage 1
- patients with atrial fibrillation
- pregnant and breast-feeding women
- patients with disturbed central nerve system
- patients with pacemaker, implants, ferrous clamps,insulin pump
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 |
|---|---|---|
| Echography GE Healthcare Vivid E9Echography GE Healthcare Vivid E9 | Device | MitraClip, TAVI |
Primary outcome
Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures
Time frame: Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echography GE Healthcare Vivid E9 in people with Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography and Aortic Stenosis, 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 8 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: finished, as of the sponsor's last update on 2 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures (time frame: Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month). 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 2 Dec 2014.