Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Recurrent Mitral Regurgitation
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Chord-X system implant (Device)
结局指标
主要结局
Recurrent Mitral Regurgitation
时间窗: 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.
次要结局
未报告次要终点