Mitral Valve InsufficiencyNCT01784055
NeoChord TACT Post-Market Surveillance Registry
An observational study of Mitral Valve Insufficiency and Heart Valve Diseases, run by NeoChord at 7 sites in 5 countries.
Trial summary
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases
- How many people
- 126 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Mar 2013to Jul 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement
Who may be able to join
- Grade 3+ or 4+ mitral valve regurgitation
Who cannot join
- Heavily calcified valves
- Valvular retraction with severely reduced mobility
- Active bacterial endocarditis
- Complex mechanism of MR (leaflet perforation, etc.)
- Significant tethering of leaflets
- Inflammatory valve disease
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany3 sites
Herzzentrum Dresden
Dresden
Asklepios Hospital St. Georg
Hamburg
University Medical Center Hamburg
Hamburg
About this study
Official title: Post-Market Surveillance Registry for the NeoChord DS1000
To monitor the long-term performance of the CE Marked NeoChord 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, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Mitral Valve Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success
To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure
Measured: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mitral Valve InsufficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- NeoChord
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joerg Seeberger, MD, Study chair, Leipzig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784055
- Sponsor's protocol ID
- 800001-001
- Status last verified
- Aug 2017
- First submitted
- 31 Jan 2013
- Last updated
- 2 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Surveillance Registry for the NeoChord DS1000
- ClinicalTrials.gov ID
- NCT01784055
- Acronym / sponsor ID
- 800001-001
- Keywords
- NeoChord, DS1000, Mitral Valve, Mitral Valve Regurgitation, MR, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- NeoChordIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 2 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement
Key inclusion criteria (1 listed)
- Grade 3+ or 4+ mitral valve regurgitation
Key exclusion criteria (6 listed)
- Heavily calcified valves
- Valvular retraction with severely reduced mobility
- Active bacterial endocarditis
- Complex mechanism of MR (leaflet perforation, etc.)
- Significant tethering of leaflets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedure Success
Time frame: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.
To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joerg Seeberger, MD study chair
Leipzig University
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Insufficiency and Heart Valve Diseases, run by NeoChord at 7 sites in 5 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 1 inclusion and 6 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, France, Italy, Lithuania, Switzerland. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Procedure Success (time frame: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.). 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 Apr 2018.