Mitral Valve RegurgitationTACTNCT01777815
Safety and Performance Study of the NeoChord Device
A study testing NeoChord DS1000 Artificial Chordae Delivery System in people with Mitral Valve Regurgitation, run by NeoChord at 8 sites in 4 countries.
Trial summary
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- NeoChord DS1000 Artificial Chordae Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Oct 2009to Aug 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 and < 80 years
- Candidate for surgical mitral valve repair or replacement
- Isolated posterior leaflet prolapse
- Moderate to severe or severe mitral valve regurgitation that is degenerative in nature
Who cannot join
- Anterior or bi-leaflet prolapse
- Functional or ischemic MR
- NYHA Class IV
- Complex mechanism of MR (leaflet perforation, etc)
- Significant tethering of leaflets toward LV apex
- Severely calcified mitral valve annulus
- Inflammatory valve disease
- Severe LV dilation
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Germany4 sites
Kerckhoff-Klinik
Bad Nauheim
Herz und Gefäß-Klinik
Bad Neustadt an der Saale
Herzzentrum Leipzig
Leipzig
Klinik für Herz-und Gefäßchirurgie
Munich
Italy2 sites
San Raffaele
Milan
Ospedale San Giovanni Battista "Molinette"
Torino
About this study
Official title: Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- NeoChord DS1000 Artificial Chordae Delivery System
- Keywords
- NeoChord, DS1000, Mitral Valve, Mitral Valve Regurgitation, MR, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoChord DS1000 Artificial Chordae Delivery SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Implanting ePTFE sutures | Experimental | Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System Receives: Device: NeoChord DS1000 Artificial Chordae Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation <= 2+ at the time of the procedure AND maintained MR reduction of <= 2+ at 30 days
Measured: 30 days
Secondary outcomes (1)
Procedural Safety
the rate of Major Adverse Events (MAE) defined as a combined endpoint of: death, MI, reoperation for failed surgical repair, non-elective cardiovascular surgery to treat an adverse event, procedural ventilation > 48 hours, procedure-related transfusion of > 2 units blood product, stroke, renal failure, deep wound infection, new onset of permanent AF, and septicemia, through 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoChord
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anno Diegeler, MD, Principal investigator, Herz und Gefäß-Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777815
- Sponsor's protocol ID
- PR-610404-100
- Other IDs
- 09/1819
- Acronym
- TACT
- Status last verified
- Sep 2014
- First submitted
- 25 Jan 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seeburger J, Rinaldi M, Nielsen SL, Salizzoni S, Lange R, Schoenburg M, Alfieri O, Borger MA, Mohr FW, Aidietis A. Off-pump transapical implantation of artificial neo-chordae to correct mitral regurgitation: the TACT Trial (Transapical Artificial Chordae Tendinae) proof of concept. J Am Coll Cardiol. 2014 Mar 11;63(9):914-9. doi: 10.1016/j.jacc.2013.07.090. Epub 2013 Sep 24.
PubMed 24076529
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT01777815
- Acronym / sponsor ID
- TACT / PR-610404-100
- Conditions
- Mitral Valve Regurgitation
- Keywords
- NeoChord, DS1000, Mitral Valve, Mitral Valve Regurgitation, MR, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NeoChordIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Jan 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.
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanting ePTFE sutures | Experimental | Device: NeoChord DS1000 Artificial Chordae Delivery SystemImplanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 and < 80 years
- Candidate for surgical mitral valve repair or replacement
- Isolated posterior leaflet prolapse
- Moderate to severe or severe mitral valve regurgitation that is degenerative in nature
Key exclusion criteria (8 listed)
- Anterior or bi-leaflet prolapse
- Functional or ischemic MR
- NYHA Class IV
- Complex mechanism of MR (leaflet perforation, etc)
- Significant tethering of leaflets toward LV apex
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 |
|---|---|---|
| NeoChord DS1000 Artificial Chordae Delivery System | Device | Implanting ePTFE sutures |
Primary outcome
Procedural Success
Time frame: 30 days
The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation <= 2+ at the time of the procedure AND maintained MR reduction of <= 2+ at 30 days
1 secondary outcome
Procedural Safety
Time frame: 30 days
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 25 Sep 2014.
- Derived from this study: PubMed 24076529Seeburger J, Rinaldi M, Nielsen SL, Salizzoni S, Lange R, Schoenburg M, Alfieri O, Borger MA, Mohr FW, Aidietis A. Off-pump transapical implantation of artificial neo-chordae to correct mitral regurgitation: the TACT Trial (Transapical Artificial Chordae Tendinae) proof of concept. J Am Coll Cardiol. 2014 Mar 11;63(9):914-9. doi: 10.1016/j.jacc.2013.07.090. Epub 2013 Sep 24.
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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.
Anno Diegeler, MD principal investigator
Herz und Gefäß-Klinik
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoChord DS1000 Artificial Chordae Delivery System in people with Mitral Valve Regurgitation, run by NeoChord at 8 sites in 4 countries.
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 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Italy, Denmark, Lithuania. 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?
Procedural Success (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01777815, which also lists 1 linked publication.
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 25 Sep 2014.