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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chord-X system implant | Device | Patients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Priya Patel | Contact | 16789843952 | priya.patel@artivion.com |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Zacharias, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35690138 | Background | 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. | |
| 26170468 | Background | Stone 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. |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Monasterio Foundation Heart Hospital | Massa | Italy |
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| Blackpool Victoria Hospital | Blackpool | United Kingdom |
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| The James Cook University Hospital | Middlesbrough | United Kingdom |
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| 40283579 | Background | Figlioli 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. |
| 28314623 | Background | Zoghbi 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. |
| 34453165 | Background | Vahanian 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. |
| 29622181 | Background | El 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. |
| 27549563 | Background | Gillinov 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. |