Mitral Valve RepairCHAGALLNCT03581656
ChordArt System for Mitral Regurgitation
A study testing ChordArt System in people with Mitral Valve Repair and Mitral Regurgitation, run by CoreMedic GmbH at 1 site in Lithuania.
Trial summary
The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Repair, Mitral Regurgitation, Mitral Valve Insufficiency
- What is being tested?
- ChordArt System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteLithuania
- Study dates
- 21 Mar 2018to Dec 2023
- 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
- Age ≥ 18 years
- Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail
- Left Ventricular Ejection Fraction >20%
- New York Heart Association functional class II to IV
- Able and willing to give informed consent and follow protocol procedures.
Who cannot join
- Life expectancy <1 year
- Hemodynamic instability
- Severe untreated ischemic disease
- Pulmonary Hypertension
- Any prior mitral valve surgery or transcatheter mitral valve procedure
- Stroke or transient ischemic event within 30 days before randomization
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- Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating.
- Renal insufficiency
- Acute anemia
- Chronic obstructive pulmonary disease
- Severe right ventricular dysfunction
- Hepatic insufficiency
- Patient is participating in other investigational studies
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08410
About this study
Official title: ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail
The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.
Read the detailed description
ChordArt utilizes a minimally invasive catheter based approach by which multiple artificial chordae are precisely positioned into the papillary muscle and then secured to the pathological leaflet.
- Being tested
- ChordArt System
- Keywords
- Degenerative Mitral Leaflet Prolapse, Heart Disease, Minimally Invasive
- Medical subject headings
- Mitral Valve Insufficiency, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChordArt SystemDevice
The ChordArt System is intended for chordal replacement in mitral valve insufficiency due to leaflet prolapse or flail. One or more ChordArt System may be utilized within the same intervention for optimal mitral valve treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm | Experimental | The ChordArt System is intended for chordal replacement in patients with mitral valve insufficiency due to leaflet prolapse or flail delivered through a catheter based technology for mitral chordal replacement via a small incision in the thorax. Receives: Device: ChordArt System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The frequency of all-cause mortality
Measured: At 30 days from implant procedure
Major adverse events
The frequency of pre-determined major adverse events
Measured: At 30 days from implant procedure
Secondary outcomes (2)
Technical Success
The technical success will be measured by the absence of procedural mortality, successful access, delivery of the ChordArt implant \& retrieval of the ChordArt delivery system as well as successful ChordArt deployment, positioning and freedom from emergency surgery or re-intervention related to the device or access procedure.
Measured: End of Implantation Procedure
Device Performance
The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography.
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start21 Mar 2018
- Primary completion10 Sep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RepairStudies 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
- Model description
- Single arm, multi-center, prospective, non-randomized study. The study is conducted in accordance with the guidelines of the Mitral Valve Academic Research Consortium (MVARC) regarding study design and endpoint definition as well as International Standards Organization 5840-3.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoreMedic GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Kestutis Rucinskas, MD, Principal investigator, Heart Surgery Centre, Santariskiu Vilnius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581656
- Sponsor's protocol ID
- PR-000274-001
- Other IDs
- CHAGALL
- Acronym
- CHAGALL
- Status last verified
- Jul 2022
- First submitted
- 4 Jun 2018
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohty D, Orszulak TA, Schaff HV, Avierinos JF, Tajik JA, Enriquez-Sarano M. Very long-term survival and durability of mitral valve repair for mitral valve prolapse. Circulation. 2001 Sep 18;104(12 Suppl 1):I1-I7. doi: 10.1161/hc37t1.094903.
PubMed 11568020Urbanski PP. Modified technique of chordal replacement for mitral valve repair. Thorac Cardiovasc Surg. 2005 Oct;53(5):315-7. doi: 10.1055/s-2005-865685.
PubMed 16208620
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail
- ClinicalTrials.gov ID
- NCT03581656
- Acronym / sponsor ID
- CHAGALL / PR-000274-001
- Keywords
- Degenerative Mitral Leaflet Prolapse, Heart Disease, Minimally Invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- CoreMedic GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 10 Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Jul 2018 (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 ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.
Detailed description
ChordArt utilizes a minimally invasive catheter based approach by which multiple artificial chordae are precisely positioned into the papillary muscle and then secured to the pathological leaflet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, multi-center, prospective, non-randomized study. The study is conducted in accordance with the guidelines of the Mitral Valve Academic Research Consortium (MVARC) regarding study design and endpoint definition as well as International Standards Organization 5840-3.
| Arm | Type | Receives |
|---|---|---|
| Arm | Experimental | Device: ChordArt SystemThe ChordArt System is intended for chordal replacement in patients with mitral valve insufficiency due to leaflet prolapse or flail delivered through a catheter based technology for mitral chordal replacement via a small incision in the thorax. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail
- Left Ventricular Ejection Fraction >20%
- New York Heart Association functional class II to IV
- Able and willing to give informed consent and follow protocol procedures.
Key exclusion criteria (13 listed)
- Life expectancy <1 year
- Hemodynamic instability
- Severe untreated ischemic disease
- Pulmonary Hypertension
- Any prior mitral valve surgery or transcatheter mitral valve procedure
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 |
|---|---|---|
| ChordArt SystemThe ChordArt System is intended for chordal replacement in mitral valve insufficiency due to leaflet prolapse or flail. One or more ChordArt System may be utilized within the same intervention for optimal mitral valve treatment. | Device | Arm |
Primary outcome
All-cause mortality
Time frame: At 30 days from implant procedure
The frequency of all-cause mortality
Major adverse events
Time frame: At 30 days from implant procedure
The frequency of pre-determined major adverse events
2 secondary outcomes
Technical Success
Time frame: End of Implantation Procedure
Device Performance
Time frame: At 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Background: PubMed 11568020Mohty D, Orszulak TA, Schaff HV, Avierinos JF, Tajik JA, Enriquez-Sarano M. Very long-term survival and durability of mitral valve repair for mitral valve prolapse. Circulation. 2001 Sep 18;104(12 Suppl 1):I1-I7. doi: 10.1161/hc37t1.094903.
- Background: PubMed 16208620Urbanski PP. Modified technique of chordal replacement for mitral valve repair. Thorac Cardiovasc Surg. 2005 Oct;53(5):315-7. doi: 10.1055/s-2005-865685.
- Sponsor's WebsiteLink provided by the sponsor.
- Collaborator's WebsiteLink provided by the sponsor.
- Recruiting SiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mitral Valve Repair
Active, not recruiting
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PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
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A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
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Edge-to-edge Mitral Valve Repair in ATTR-CM
Mitral Regurgitation, ATTR-Cardiomyopathy
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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.
Kestutis Rucinskas, MD principal investigator
Heart Surgery Centre, Santariskiu Vilnius
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChordArt System in people with Mitral Valve Repair and Mitral Regurgitation, run by CoreMedic GmbH at 1 site in Lithuania.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. 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 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?
Results are not available in the source record.
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?
All-cause mortality (time frame: At 30 days from implant procedure). The study lists 2 primary outcomes in all. 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 NCT03581656, which also lists 2 linked publications.
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 12 Jul 2022.