Safety and Performance Study of the MitralStitch Repair System.

NCT04080362 | Unknown

• 1 other identifier: MIRACLE_II
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.

Conditions

Mitral Regurgitation

Keywords

Mitral Regurgitation; Mitral Valve Repair; Transapical

Outcome Measures

Primary Outcomes (1)

• The success rate

  Combined incidence of freedom from: death, surgery for Valve Dysfunction, and MR \> 2+ (moderate to severe (3+) or severe (4+) mitral regurgitation) at 12 months

  1 year

Secondary Outcomes (6)

• The instant procedural success

  Immediately after repair

• The success of the repair system

  12 months

• The success of the surgery

  1 month

• New York Heart Association (NYHA) class

  12 months

• Living quality

  12 months

Study Arms (1)

MitralStitch repair system

EXPERIMENTAL

Experimental group is allocated to use novel mitral vavle repair system manufactured by Hangzhou Valgen Medtech Co., Ltd

Device: MitralStitch

Interventions

MitralStitch DEVICE

With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial neochordae or ege-to-ege repair using MitralStitch System

MitralStitch repair system

Eligibility Criteria

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

You may qualify if:

• Age ≥18 yrs
• Moderate to severe (3+) or severe (4+) mitral valve regurgitation confirmed by echocardiography (defined as MR \>2+);
• NYHA functional class II-V (Appendix 3);
• Anatomically suitable for mitral valve repair;
• mm ≤LVESD≤55 mm; 25% ≤LVEF ≤60%; tolerable for small incision thoracic surgery;
• Mitral valve diameter ≤45mm;
• The independent expert committee of this study determined that surgical operation was contraindicated or high-risk, and the recommended reference standard was: surgical valve replacement with STS score ≥ 8； or surgical valve repair with STS score ≥ 6； or other risk factors (e.g., There are at least two moderate to severe indicators of weakness; potential operational disorders; at least major organ dysfunction that cannot be improved after surgery, etc.)
• The subject or the subject's legal representative fully understand and agree to join to the clinic trial.

You may not qualify if:

• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Severe mitral valve calcification;
• Concomitant with greater than moderate aortic stenosis or regurgitation;
• Mitral regurgitation caused by special pathological mechanisms, such as leaflet perforation and leaflet fissure;
• Severe untreated coronary artery stenosis requiring revascularization; or with other cardiovascular disease requiring surgical treatment;
• Hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart diseases that cause heart failure in patients expect dilated cardiomyopathy;
• Myocardial infarction was performed within 4 weeks before the intervention;
• Any vascular intervention, cardiac surgery, cardiac resynchronization therapy (CRT, CRT-D), and an implantation of implantable cardioverter defibrillator (ICD) were performed within 30 days before the intervention;
• Any heart transplantation, mitral valve surgery or percutaneous mitral valve operation were performed before the intervention;
• Life expectancy is less than 12 months;
• History of, or active, rheumatic heart disease;
• Active phase of bacterial endocarditis;
• The active infections require concurrent antibiotic treatment;
• History of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
• Dysplasia of the blood system, including granulocytopenia (WBC \< 3×109/L), acute anemia (HB \< 90g/L), thrombocytopenia (PLT \< 50×109/L), hemorrhagic constitution, and coagulopathy；

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead

Study Sites (1)

Structural Heart Disease Center, Fuwai Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Shengshou Hu

  Chinese Academy of Medical Science, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The clinical trial was designed as a single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transapical beating-heart mitral valve repair surgery using MitralStitchTM mitral valve repair system.

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: September 6, 2019
• Study Start: July 5, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: February 28, 2020

Record last verified: 2019-05

Locations

CN (1)