Mitral Regurgitation (MR)METRIXNCT07413926
Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
An observational study of Mitral Regurgitation (MR), run by Artivion Inc. at 4 sites in 3 countries.
Trial summary
The goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data (out to 10 years). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation (MR)
- What is being tested?
- Chord-X system implant
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jun 2026to Jun 2034
- How long will I take part?
- 10 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In this study, all patients who underwent a mitral valve procedure (defined as a mitral valve surgical intervention via either endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System, as clinically indicated, approximately 3 years prior to enrollment (beginning in January 2022), will be approached for participation in the study. Approximately 110 patients will be enrolled at five medical centers in the UK, EU and the United States. To ensure balanced representation across centers, each center will be expected to enroll a minimum of 15 patients and a maximum of 30 patients. 110 patients are planned for enrollment with the possibility to recruit up to 10 more patients for a total of 120 patients. Data from all patients adequately enrolled will be included in the analysis of results.
Who may be able to join
- Patient provided written Informed Consent
- Patient underwent mitral valve procedure (defined as mitral valve surgical intervention via endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System as clinically indicated (i.e. not off-label) by Principal Investigator at research site
- Patient's Chord-X System implant occurred no earlier than January 1, 2022
- Patient is able and willing to participate in follow-up visits for the duration of the study (i.e. through 10 years post-op)
Who cannot join
- Patient was implanted with the Chord-X System off-label
- Patient was implanted with the Chord-X System prior to January 1, 2022
- Patient has had previous mitral valve surgery
- Patient underwent a multi valve repair procedure
- Patient with an ejection fraction ≤ 50% at baseline
- Patient underwent concomitant surgical procedures (except for maze procedure, PFO or LAA closure) at time of mitral repair procedure
Show all 10Show fewer
- Patient whose mitral valve procedure was performed as part of an emergency surgery (defined as a time period from diagnosis to surgery of ≤ 48 hours)
- Patient with persistent or permanent atrial fibrillation
- Patient with active or a history of endocarditis
- Patient with congenital heart disease
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United Kingdom2 sites
Blackpool Victoria Hospital
Blackpool
Vasanthi Vasudevan, vasanthi.vasudevan@nhs.net
The James Cook University Hospital
Middlesbrough
Carmen Neave, carmen.neave@nhs.net
United States1 site
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Cynthia Mulcahy, Cynthia.Mulcahy@stelizabeth.com
Italy1 site
Monasterio Foundation Heart Hospital
Massa
Alessandra Parlanti, alessandra.parlanti@ftgm.it
About this study
The goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data (out to 10 years). Collecting patient health information over time can help to supplement and improve the care of patients in the future.
Participants will:
Agree to the collection of their past medical history, and the details of their mitral repair surgery with the Chord-X system, including results of the follow-up examinations after implantation Visit the clinic for the routinely scheduled follow-up examination appointments
Read the detailed description
The Chord-X Mitral Chordal Replacement System (Chord-X System) is indicated for the treatment of patients with mitral regurgitation who are not at high surgical risk as judged by a multidisciplinary heart team. It is a premade artificial suture system comprised of the Chord-X Adjustable Sutures or Chord-X Pre-Measured Loops, and Chord-X® Chordal Sizer. The Chord-X Suture System or Chord-X Pre-Measured Loops are intended to replace the chordae tendinae during a surgical mitral valve repair procedure to treat patients with mitral regurgitation due to defective native mitral valve chords (i.e., ruptured or elongated native chords). The Choral Sizer is intended to assist the surgeon in determining the length of the chordal tendinae to be replaced, for selection of the Chord-X loop size (pre-measured or adjusted). The Chord-X System is intended for use by trained cardiac surgeons with experience in performing mitral valve repair procedures.
The study is initiated to strengthen the body of evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant, to evaluate long-term (10 years) clinical benefit, safety, and performance data from use in the real-world setting.
This is a multicenter, single arm, retrospective \& prospective study collecting anonymized data from past and future records of patients who meet the following patient population criteria: Patients, who underwent a mitral valve procedure (defined as a mitral valve surgical intervention via either endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System, as clinically indicated per the standard of care, at a high-volume center, whose surgery occurred beginning in January 2022 (approximately 3 years prior to enrolment).
110 patients (+ up to 10 patients) will be enrolled in up to five clinical centers.
The primary study endpoint is recurrent moderate to severe (3+) mitral regurgitation. Secondary endpoints are all cause mortality and reoperation for recurrent mitral regurgitation.
Mitral regurgitation severity is classified as none/trivial (0), mild (1+), moderate (2+), moderate to severe (3+) or severe (4+). The wording moderate to severe is used to describe the upper end of the moderate range. The process of grading MR is comprehensive, using a combination of clues, signs and measurements obtained by Doppler echocardiography. If there are signs suggesting that MR is more than mild, quantitative methods (including mean gradient and ejection fraction) are used to determine the degree of MR .
This study involves a hybrid (retrospective and prospective) data collection from patients who have already been implanted with the Chord-X System. It is a multicenter, international, open label registry collecting real-world data from patients who underwent endoscopic or sternotomy mitral valve repair using the Chord-X System, as clinically indicated, approximately 3 years prior to enrolment (beginning in January 2022).
- Conditions
- Mitral Regurgitation (MR)
- Being tested
- Chord-X system implant
- Keywords
- mitral regurgitation, Chord-X
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chord-X system implantDevice
Patients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent mitral repair with Chord-X system beginning in January 2022 | all patients who underwent a mitral valve procedure (defined as a mitral valve surgical intervention via either endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System, as clinically indicated, beginning in January 2022, will be approached for participation in the study. Receives: Device: Chord-X system implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Mitral Regurgitation
The primary endpoint of the study is recurrent moderate to severe (3+) mitral regurgitation (MR). Mitral regurgitation severity is classified as none/trivial (0), mild (1+), moderate (2+), moderate to severe (3+) or severe (4+). The wording moderate to severe is used to describe the upper end of the moderate range. The process of grading MR is comprehensive, using a combination of clues, signs and measurements obtained by Doppler echocardiography.
Measured: The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startJun 2026 (estimated)
- Primary completionMar 2034 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mitral Regurgitation (MR)Studies 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
- 110 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Artivion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Zacharias, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413926
- Sponsor's protocol ID
- CHX2401.000-M (08/24)
- Acronym
- METRIX
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lang M, Vitanova K, Voss B, Feirer N, Rheude T, Krane M, Gunther T, Lange R. Beyond the 10-Year Horizon: Mitral Valve Repair Solely With Chordal Replacement and Annuloplasty. Ann Thorac Surg. 2023 Jan;115(1):96-103. doi: 10.1016/j.athoracsur.2022.05.036. Epub 2022 Jun 9.
PubMed 35690138Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015 Aug 1;36(29):1878-91. doi: 10.1093/eurheartj/ehv333. Epub 2015 Jul 13.
PubMed 26170468Figlioli G, Sticchi A, Christodoulou MN, Hadjidemetriou A, Amorim Moreira Alves G, De Carlo M, Praz F, Caterina R, Nikolopoulos GK, Bonovas S, Piovani D. Global Prevalence of Mitral Regurgitation: A Systematic Review and Meta-Analysis of Population-Based Studies. J Clin Med. 2025 Apr 16;14(8):2749. doi: 10.3390/jcm14082749.
PubMed 40283579Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
PubMed 28314623Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
PubMed 34453165El Sabbagh A, Reddy YNV, Nishimura RA. Mitral Valve Regurgitation in the Contemporary Era: Insights Into Diagnosis, Management, and Future Directions. JACC Cardiovasc Imaging. 2018 Apr;11(4):628-643. doi: 10.1016/j.jcmg.2018.01.009.
PubMed 29622181Gillinov M, Quinn R, Kerendi F, Gaudiani V, Shemin R, Barnhart G, Raines E, Gerdisch MW, Banbury M. Premeasured Chordal Loops for Mitral Valve Repair. Ann Thorac Surg. 2016 Sep;102(3):e269-e271. doi: 10.1016/j.athoracsur.2016.03.018.
PubMed 27549563
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
- ClinicalTrials.gov ID
- NCT07413926
- Acronym / sponsor ID
- METRIX / CHX2401.000-M (08/24)
- Conditions
- Mitral Regurgitation (MR)
- Keywords
- mitral regurgitation, Chord-X
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Artivion Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2034 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 17 Feb 2026 (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 goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data (out to 10 years). Collecting patient health information over time can help to supplement and improve the care of patients in the future.
Participants will:
Agree to the collection of their past medical history, and the details of their mitral repair surgery with the Chord-X system, including results of the follow-up examinations after implantation Visit the clinic for the routinely scheduled follow-up examination appointments
Detailed description
The Chord-X Mitral Chordal Replacement System (Chord-X System) is indicated for the treatment of patients with mitral regurgitation who are not at high surgical risk as judged by a multidisciplinary heart team. It is a premade artificial suture system comprised of the Chord-X Adjustable Sutures or Chord-X Pre-Measured Loops, and Chord-X® Chordal Sizer. The Chord-X Suture System or Chord-X Pre-Measured Loops are intended to replace the chordae tendinae during a surgical mitral valve repair procedure to treat patients with mitral regurgitation due to defective native mitral valve chords (i.e., ruptured or elongated native chords). The Choral Sizer is intended to assist the surgeon in determining the length of the chordal tendinae to be replaced, for selection of the Chord-X loop size (pre-measured or adjusted). The Chord-X System is intended for use by trained cardiac surgeons with experience in performing mitral valve repair procedures.
The study is initiated to strengthen the body of evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant, to evaluate long-term (10 years) clinical benefit, safety, and performance data from use in the real-world setting.
This is a multicenter, single arm, retrospective \& prospective study collecting anonymized data from past and future records of patients who meet the following patient population criteria: Patients, who underwent a mitral valve procedure (defined as a mitral valve surgical intervention via either endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System, as clinically indicated per the standard of care, at a high-volume center, whose surgery occurred beginning in January 2022 (approximately 3 years prior to enrolment).
110 patients (+ up to 10 patients) will be enrolled in up to five clinical centers.
The primary study endpoint is recurrent moderate to severe (3+) mitral regurgitation. Secondary endpoints are all cause mortality and reoperation for recurrent mitral regurgitation.
Mitral regurgitation severity is classified as none/trivial (0), mild (1+), moderate (2+), moderate to severe (3+) or severe (4+). The wording moderate to severe is used to describe the upper end of the moderate range. The process of grading MR is comprehensive, using a combination of clues, signs and measurements obtained by Doppler echocardiography. If there are signs suggesting that MR is more than mild, quantitative methods (including mean gradient and ejection fraction) are used to determine the degree of MR .
This study involves a hybrid (retrospective and prospective) data collection from patients who have already been implanted with the Chord-X System. It is a multicenter, international, open label registry collecting real-world data from patients who underwent endoscopic or sternotomy mitral valve repair using the Chord-X System, as clinically indicated, approximately 3 years prior to enrolment (beginning in January 2022).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent mitral repair with Chord-X system beginning in January 2022 | – | Device: Chord-X system implantall patients who underwent a mitral valve procedure (defined as a mitral valve surgical intervention via either endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System, as clinically indicated, beginning in January 2022, will be approached for participation in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this study, all patients who underwent a mitral valve procedure (defined as a mitral valve surgical intervention via either endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System, as clinically indicated, approximately 3 years prior to enrollment (beginning in January 2022), will be approached for participation in the study. Approximately 110 patients will be enrolled at five medical centers in the UK, EU and the United States. To ensure balanced representation across centers, each center will be expected to enroll a minimum of 15 patients and a maximum of 30 patients. 110 patients are planned for enrollment with the possibility to recruit up to 10 more patients for a total of 120 patients. Data from all patients adequately enrolled will be included in the analysis of results.
Key inclusion criteria (4 listed)
- Patient provided written Informed Consent
- Patient underwent mitral valve procedure (defined as mitral valve surgical intervention via endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System as clinically indicated (i.e. not off-label) by Principal Investigator at research site
- Patient's Chord-X System implant occurred no earlier than January 1, 2022
- Patient is able and willing to participate in follow-up visits for the duration of the study (i.e. through 10 years post-op)
Key exclusion criteria (10 listed)
- Patient was implanted with the Chord-X System off-label
- Patient was implanted with the Chord-X System prior to January 1, 2022
- Patient has had previous mitral valve surgery
- Patient underwent a multi valve repair procedure
- Patient with an ejection fraction ≤ 50% at baseline
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 |
|---|---|---|
| Chord-X system implantPatients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022 | Device | Patients who underwent mitral repair with Chord-X system beginning in January 2022 |
Primary outcome
Recurrent Mitral Regurgitation
Time frame: The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant.
The primary endpoint of the study is recurrent moderate to severe (3+) mitral regurgitation (MR). Mitral regurgitation severity is classified as none/trivial (0), mild (1+), moderate (2+), moderate to severe (3+) or severe (4+). The wording moderate to severe is used to describe the upper end of the moderate range. The process of grading MR is comprehensive, using a combination of clues, signs and measurements obtained by Doppler echocardiography.
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 20 Feb 2026.
- Background: PubMed 35690138Lang M, Vitanova K, Voss B, Feirer N, Rheude T, Krane M, Gunther T, Lange R. Beyond the 10-Year Horizon: Mitral Valve Repair Solely With Chordal Replacement and Annuloplasty. Ann Thorac Surg. 2023 Jan;115(1):96-103. doi: 10.1016/j.athoracsur.2022.05.036. Epub 2022 Jun 9.
- Background: PubMed 26170468Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015 Aug 1;36(29):1878-91. doi: 10.1093/eurheartj/ehv333. Epub 2015 Jul 13.
- Background: PubMed 40283579Figlioli G, Sticchi A, Christodoulou MN, Hadjidemetriou A, Amorim Moreira Alves G, De Carlo M, Praz F, Caterina R, Nikolopoulos GK, Bonovas S, Piovani D. Global Prevalence of Mitral Regurgitation: A Systematic Review and Meta-Analysis of Population-Based Studies. J Clin Med. 2025 Apr 16;14(8):2749. doi: 10.3390/jcm14082749.
- Background: PubMed 28314623Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
- Background: PubMed 34453165Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
- Background: PubMed 29622181El Sabbagh A, Reddy YNV, Nishimura RA. Mitral Valve Regurgitation in the Contemporary Era: Insights Into Diagnosis, Management, and Future Directions. JACC Cardiovasc Imaging. 2018 Apr;11(4):628-643. doi: 10.1016/j.jcmg.2018.01.009.
- Background: PubMed 27549563Gillinov M, Quinn R, Kerendi F, Gaudiani V, Shemin R, Barnhart G, Raines E, Gerdisch MW, Banbury M. Premeasured Chordal Loops for Mitral Valve Repair. Ann Thorac Surg. 2016 Sep;102(3):e269-e271. doi: 10.1016/j.athoracsur.2016.03.018.
- 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.
Joseph Zacharias, MD principal investigator
4 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 (MR), run by Artivion Inc. at 4 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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, United States, Italy. 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 Priya Patel (16789843952, priya.patel@artivion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Mitral Regurgitation (time frame: The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant.). 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 NCT07413926, which also lists 7 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 20 Feb 2026.