European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation

NCT05425628 | Unknown DMC

• 1 other identifier: PR-610710-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.

Conditions

Mitral Valve Insufficiency; Mitral Valve Prolapse; Degenerative; Mitral Regurgitation; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Keywords

NeoChord; Mitral Valve Regurgitation; Mitral Valve Prolapse; Artificial Chordae; Mitral Valve Repair

Outcome Measures

Primary Outcomes (2)

• The ability of the NeoChord device to be placed without Major Device Related Adverse Events.

  * 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); * Arrhythmia and 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.

  30 days

• NeoChord Technical Success

  * 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.

  30 days

Secondary Outcomes (6)

• Secondary performance endpoints (MR severity)

  30 days, 90 days, and 180 days post-index procedure

• Secondary performance endpoints (MR severity)

  30 days, 90 days, and 180 days post-index procedure

• Secondary performance endpoints (Patient Success)

  30 days, 90 days, and 180 days post-index procedure

• Secondary performance endpoints (Patient Success)

  30 days, 90 days, and 180 days post-index procedure

• Secondary performance endpoints (Patient Success)

  30 days, 90 days, and 180 days post-index procedure

Study Arms (1)

Treatment with NeoChord Transcatheter Mitral Repair System

EXPERIMENTAL

Implanting ePTFE sutures as artificial neochordae using NeoChord Transcatheter Mitral Repair System

Device: NeoChord Transcatheter Mitral Repair System (or "NeoChord System")

Interventions

NeoChord Transcatheter Mitral Repair System (or "NeoChord System") DEVICE

The NeoChord Transcatheter Mitral Repair System is a system of delivery devices and implantable Neochordae and Anchor. The system is designed to percutaneously deliver and deploy the implantable ePTFE sutures, "Neochordae" as artificial chordae at the mitral valve and connect them to the implantable ventricular anchor, "Anchor", using a catheter based system placed into the left side of the heart through the interatrial septum.

Treatment with NeoChord Transcatheter Mitral Repair System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age is 18 to 85 years at time of enrollment.
• Symptomatic MR (≥3+) confirmed by the echo core lab.
• 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, confirmed by the echo core lab.
• Leaflet-to-Annulus Index (LAI) ≥ 1.25 based on 2D TEE, confirmed by the echo core lab. (1)
• Cardiac Index \> 2.0.
• Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE).
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa.
• Subject deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one cardiac surgeon, one interventional cardiologist, and a cardiac imaging expert).
• Transseptal catheterization is deemed feasible by the Subject Screening Committee.
• The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions including returning for all follow-up visits and has provided written informed consent.

You may not qualify if:

• MR etiology that is exclusively Secondary (functional).
• Echocardiographic evidence of EROA ≤ 0.3cm2.
• Valvular leaflet anatomy or pathology deemed not suitable for the NeoChord Implant.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than cardiomyopathy of either ischemic or non-ischemic etiology.
• Hypotension (systolic pressure \< 90 mmHg)/Cardiogenic shock or other hemodynamic instability requiring theneed for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
• Fixed pulmonary artery systolic pressure \> 2/3 of systemic systolic blood pressure.
• Evidence of right-sided heart failure with echocardiographic evidence of severe right ventricular dysfunction.
• Surgical or interventional procedure planned within 30 days prior to index procedure.
• Prior orthotropic heart transplantation.
• Life Expectancy \< 1 year due to non-cardiac conditions.
• Chronic Kidney Disease with Creatinine clearance \<30 ml/min/1.73m2.
• Any prior mitral valve surgery or transcatheter mitral valve procedure.
• Stroke, transient ischemic event, or myocardial infarction within 30 Days prior to index procedure.
• ModifiedRankinScale\>4disability.

Sponsors & Collaborators

• NeoChord: lead

MeSH Terms

Conditions

Mitral Valve Insufficiency; Mitral Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Valve Prolapse

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, unblinded, single arm first in human/feasibility clinical study.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 21, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06