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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
- ClinicalTrials.gov ID
- NCT04190602
- Acronym / sponsor ID
- AcChord / PR-610414-101
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse, Heart Valve Diseases
- Keywords
- NeoChord, DS1000, Artificial Chordae, Mitral Valve Repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NeoChordIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Dec 2019 (actual)
- 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
- Study procedure completed after 31 December 2016
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoChord Artificial Chordae Delivery System, Model DS1000Also: NeoChord DS1000, DS1000The 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. | Device | – |
Primary outcome
Level of Mitral Regurgitation Following the Index Procedure
Time frame: Completion of Index Procedure
Level of mitral regurgitation per echocardiography
6 secondary outcomes
Level of Mitral Regurgitation at 3-6 Months
Time frame: 3-6 Months
Level of Mitral Regurgitation at 1 Year
Time frame: 1 Year
Level of Mitral Regurgitation at 2 Years
Time frame: 2 Years
Level of Mitral Regurgitation at 3 Years
Time frame: 3 Years
Level of Mitral Regurgitation at 4 Years
Time frame: 4 Years
Level of Mitral Regurgitation at 5 Years
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Andres Beiras Fernandez, MD PhD principal investigator
Johannes Gutenberg University Mainz
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Mitral Valve Disease, run by NeoChord at 5 sites in 3 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 2 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: looking for participants now, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Greece, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandar Jonkers (+31 610740977, ajonkers@neochord.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Mitral Regurgitation Following the Index Procedure (time frame: Completion of Index Procedure). 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 10 Jul 2020.