Mitral Valve Repair With the Chord-X System: A Long Term Evaluation

Обзор

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

Подробное описание

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).

Вмешательства

• Устройство Chord-X system implant
  Patients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022

Первичные конечные точки

• Recurrent Mitral Regurgitation [Срок оценки: The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 2 центра

• Blackpool Victoria Hospital — Blackpool
• The James Cook University Hospital — Middlesbrough

США · 1 центр

• St. Elizabeth Healthcare — Edgewood

Италия · 1 центр

• Monasterio Foundation Heart Hospital — Massa

Публикации

• 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. PMID 35690138
• 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 Co PMID 26170468
• 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. PMID 40283579
• 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 PMID 28314623
• 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 PMID 34453165
• 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. PMID 29622181
• 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. PMID 27549563

Идентификаторы

NCT: NCT07413926 · CHX2401.000-M (08/24)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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