Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation

NCT06021509 | Active Not Recruiting

• 1 other identifier: YM-2022-001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To validate the safety and efficacy of transcatheter edge-to-edge repair (TEER) using the NovoClasp® transcatheter mitral valve clip and steerable guide catheter in the treatment of moderate to severe and severe degenerative mitral regurgitation (DMR).

Conditions

Degenerative Mitral Valve Disease

Keywords

transcatheter edge-to-edge repair

Outcome Measures

Primary Outcomes (1)

• Treatment effectiveness rate

  Treatment effectiveness is defined as the success of the procedure with the mitral valve regurgitation sustained at moderate or lower (\<=2+) after the surgery, without major adverse events or secondary interventions (interventional or surgical).

  1 year

Secondary Outcomes (4)

• Procedural success rate

  immediately after procedure

• Procedural success rate

  During the perioperative period

• Rate of Treatment success

  30 days, 180 days

• Changes in New York Heart Association (NYHA) Functional Classification

  through study completiong, an average of 1 year.

Other Outcomes (5)

• All cause mortality

  through study completion, an average of 1 year

• Device/Procedure-related mortality

  through study completion, an average of 1 year

• Major adverse events

  through study completion, an average of 1 year

Study Arms (1)

NovoClasp system

EXPERIMENTAL

Device: NovoClasp® transcatheter mitral valve clip and steerable guide catheter

Interventions

NovoClasp® transcatheter mitral valve clip and steerable guide catheter DEVICE

The experimental device is a class III implanted valve device, which will be used to treat the mitral valve regurgitation via transcatheter edge-to-edge repair.

Also known as: transcatheter edge-to-edge repair for mitral valve

NovoClasp system

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all of the following criteria to be eligible for this study.
• Age 18 years.
• Willingness to comply with the protocol requirements and data collection procedures, ability to understand the purpose of the trial, voluntary participation, and signing of informed consent by the subject or legal guardian.
• Confirmation by echocardiography of moderate to severe (3+) or severe (4+) degenerative mitral regurgitation.
• Echocardiography showing left ventricular ejection fraction 30%, left ventricular end-systolic diameter (LVESD) 60mm, and pulmonary artery systolic pressure (PASP) 70 mmHg.
• NYHA functional classification II-IV.
• Presence of a primary regurgitant jet; if a secondary regurgitant jet is present, it should be clinically insignificant based on investigator assessment.
• Evaluated by a multidisciplinary team as suitable for the investigational procedure using the study device.
• Society of Thoracic Surgeons (STS) score 4 or evaluated as high surgical risk for mitral valve repair by two cardiac surgeons.

You may not qualify if:

• Subjects meeting any of the following criteria are not eligible for this study.
• History of prior mitral valve surgery or heart transplant.
• Severe organ dysfunction that may affect study evaluation, including but not limited to:
• Right heart failure or biventricular heart failure.
• Severe restrictive or obstructive lung disease (COPD) requiring continuous oxygen therapy or oral steroid treatment.
• Severe renal insufficiency requiring or likely to require continuous renal replacement therapy (CRRT) or dialysis postoperatively.
• Severe carotid artery stenosis confirmed by imaging to be \>70%.
• History of cerebrovascular accident within the past 1 month.
• Acute deep vein thrombosis or acute pulmonary embolism history.
• Any known active infection.
• Active infective endocarditis (eligible 6 weeks after standard antimicrobial treatment), rheumatic heart valve disease, or radiation-induced valve disease.
• Cardiac or major vascular surgical or interventional procedure within 30 days (coronary angiography is allowed).
• Coexisting moderate or greater valvular disease (aortic valve, tricuspid valve, pulmonary valve stenosis or regurgitation).
• Known other cardiac or major vascular diseases requiring surgical or interventional intervention, including but not limited to coronary artery disease, myocardial disease, aortic disease (except for coronary angiography).
• Echocardiographic evidence of intracardiac mass, thrombus, vegetation, or mitral valve orifice area (MVOA) 4.0 cm2, or any condition unsuitable for the study device, including but not limited to:

Sponsors & Collaborators

• Enlight Medical Technologies (Shanghai) Co., Ltd: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Study Design

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

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 1, 2023
• Study Start: May 15, 2022
• Primary Completion: June 25, 2024
• Study Completion (Estimated): June 25, 2028
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

CN (1)