Mitral RegurgitationAcChordNCT04190602
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
An observational study of Mitral Regurgitation and Mitral Valve Disease, run by NeoChord at 5 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency
- What is being tested?
- NeoChord Artificial Chordae Delivery System, Model DS1000
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 9 Feb 2020to Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
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
Study population: Adult patients who meet the indications and are not contraindicated for treatment by the NeoChord Artificial Chordae Delivery System, Model DS1000.
Who may be able to join
- Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
- Study procedure completed after 31 December 2016
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
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Germany3 sites, 3 recruiting
- Recruiting
University of Bonn
Bonn
Georg Nickenig, MD
- Recruiting
CVC Frankfurt
Frankfurt
Horst Sievert, MD PhD
- Recruiting
University of Mainz
Mainz
Andres Beiras Fernandez, MD PhD
Greece1 site, 1 recruiting
- Recruiting
Hippokration Hospital
Athens
Vasileios Lozos, MD
Switzerland1 site, 1 recruiting
- Recruiting
Triemli Hospital
Zurich
Omer Dzemali, MD
About this study
Official title: The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.
Read the detailed description
This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse, Heart Valve Diseases
- Being tested
- NeoChord Artificial Chordae Delivery System, Model DS1000
- Keywords
- NeoChord, DS1000, Artificial Chordae, Mitral Valve Repair
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoChord Artificial Chordae Delivery System, Model DS1000Device
Also called NeoChord DS1000, DS1000
The intended use of the device is for the placement of artificial chordae when the natural chordae tendinae have become elongated or ruptured due to degenerative valve disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Mitral Regurgitation Following the Index Procedure
Level of mitral regurgitation per echocardiography
Measured: Completion of Index Procedure
Secondary outcomes (6)
Level of Mitral Regurgitation at 3-6 Months
Level of mitral regurgitation per echocardiography
Measured: 3-6 Months
Level of Mitral Regurgitation at 1 Year
Level of mitral regurgitation per echocardiography
Measured: 1 Year
Level of Mitral Regurgitation at 2 Years
Level of mitral regurgitation per echocardiography
Measured: 2 Years
Level of Mitral Regurgitation at 3 Years
Level of mitral regurgitation per echocardiography
Measured: 3 Years
Level of Mitral Regurgitation at 4 Years
Level of mitral regurgitation per echocardiography
Measured: 4 Years
Level of Mitral Regurgitation at 5 Years
Level of mitral regurgitation per echocardiography
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start9 Feb 2020
- Primary completionOct 2022 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- NeoChord
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andres Beiras Fernandez, MD PhD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190602
- Sponsor's protocol ID
- PR-610414-101
- Acronym
- AcChord
- Status last verified
- Jul 2020
- First submitted
- 4 Dec 2019
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No