1) Severe Mitral Regurgitation 2) Severely leaking heart valve
Conditions
Interventions
The study procedure includes the following steps:
1. NeoChord System is selected per IFU preoperatively with appropriate imaging
methods.
2. The subject is prepared as per institution*s standard prac
Sponsors
NeoChord, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject age >=18 years at time of enrollment. 2. Severe MR present, per applicable guidelines for the management of valvular heart disease (e.g., 2021 ESC/EACTS Guidelines , 2020 ACC/AHA Guideline ). 3. Primary segmental prolapse or flail of P2 segment only, or P2 segmental prolapse or flail extending to one adjacent segment (P1 or P3), and the primary regurgitant jet is non-commissural. 4. Cardiac symptoms present (NYHA Functional Class II, III, or ambulatory IVa) OR asymptomatic and a candidate for primary MR surgical repair (based on anatomical criteria) 5. Intermediate or high surgical risk, or other unfavorable factors present, as determined by the site Heart Team and adjudicated by the Independent Subject Screening Committee.
Exclusion criteria
Exclusion criteria: 1. Surgical or interventional procedure planned or performed within 30days prior to index procedure or planned interventional procedure which may require guidewire placement in left ventricle within 90 days after index procedure. 2. Stroke, transient ischemic event, or myocardial infarction within 30 Days prior to index procedure 3. Aortic or pulmonic valve disease requiring surgery 4. Echocardiographic evidence of severe right ventricular dysfunction 5. Valvular leaflet anatomy or pathology deemed not suitable for the NeoChord implant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint is the ability of the NeoChord device to be placed without Major Device Related Adverse Events through thirty (30) days including: • Death (Cardiovascular mortality vs non-cardiovascular); • Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; • Disabling stroke; • Myocardial infarction (MVARC definition); • Major access site and vascular complications; • Fatal or life-threatening bleeding (MVARC Type III-V); • Significant arrhythmia or conduction disorder requiring permanent pacing; • Renal Failure requiring dialysis; • Cardiac tamponade. All other SAE*s and device/procedure-related AE*s will be summarized throughout the follow-up duration, as descriptive endpoint data. Primary performance endpoint (NeoChord Technical Success) is defined as: • Successful access, delivery, and retrieval of the delivery system; and • Successful deployment and correct positioning of the implant; and • Freedom from emergency surgery or reintervention related to the device or access procedure Without any procedural mortality or stroke, at 30-day follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following Secondary Performance Endpoints (Patient Success) will be evaluated at 1-month, 6-month, and 12-month post-index procedure, unless otherwise noted. • Intra-procedure (following device implant) MR severity is reduced by at least 1 grade from baseline (e.g., from severe to moderate). • Post-index procedure (discharge or within 7 Days post-index procedure, whichever is earliest) MR severity is reduced by at least 1 grade from baseline (e.g., from severe to moderate). • Post-index procedure (discharge or within 7 Days post-index procedure, whichever is earliest) MR severity is reduced by 2 grades from baseline (e.g., from severe to mild). • MR severity grade • Change in LV End diastolic volume index (LVEDVI) • Change in LV end-systolic volume index (LVESVI) • Changes in NYHA functional Class • 6-minute walk test distance • Kansas City Cardiomyopathy Questionnaire score | — |
Countries
Netherlands
Outcome results
None listed