Safety and Performance Study of the MitralStitch Repair System.

A Prospective, Multicenter, Single Group Assignment Study for Evaluating the Safety and Effectiveness of MitralStitch Mitral Valve Repair System in Patients With Moderate to Severe and Severe Mitral Regurgitation.

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.

Study Overview

• Status: Unknown
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: MitralStitch

Detailed Description

The clinical trial was designed as a prospective, multicenter, 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 MitralStitch mitral valve repair system after signed the informed consent. The follow-up will be conducted after 30 days, 3 months, 6 months and 12 months of the operation.

The following conditions evaluate the performance of the system and the safety and efficiency of using MitralStitch mitral valve repair system in treating patients with severe mitral regurgitation.

The none occurrence of these conditions will be approved as the main validity index: death, mitral valve related surgery without mitral valve failure and moderate or severe mitral regurgitation (MR > 2+). The secondary validity index was technical success rate, instrument success rate, surgical success rate, cardiac function improvement and quality of life improvement. And the safety evaluation indicators were assessed by the incidence of major adverse events, adverse events, serious adverse events, and device defects.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Structural Heart Disease Center, Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 yrs
2. Moderate to severe (3+) or severe (4+) mitral valve regurgitation confirmed by echocardiography (defined as MR >2+);
3. NYHA functional class II-V (Appendix 3);
4. Anatomically suitable for mitral valve repair;
5. 40mm ≤LVESD≤55 mm; 25% ≤LVEF ≤60%; tolerable for small incision thoracic surgery;
6. Mitral valve diameter ≤45mm;
7. 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.)
8. The subject or the subject's legal representative fully understand and agree to join to the clinic trial.

Exclusion Criteria:

1. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
2. Severe mitral valve calcification;
3. Concomitant with greater than moderate aortic stenosis or regurgitation;
4. Mitral regurgitation caused by special pathological mechanisms, such as leaflet perforation and leaflet fissure;
5. Severe untreated coronary artery stenosis requiring revascularization; or with other cardiovascular disease requiring surgical treatment;
6. Hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart diseases that cause heart failure in patients expect dilated cardiomyopathy;
7. Myocardial infarction was performed within 4 weeks before the intervention;
8. 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;
9. Any heart transplantation, mitral valve surgery or percutaneous mitral valve operation were performed before the intervention;
10. Life expectancy is less than 12 months;
11. History of, or active, rheumatic heart disease;
12. Active phase of bacterial endocarditis;
13. The active infections require concurrent antibiotic treatment;
14. History of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
15. 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；
16. Modified Rankin scale ≥4；
17. Pregnant or lactating women;
18. The subject is suffered from a disease which may cause difficulty in evaluating the treatment (e.g., cancer, infection, severe metabolic disease, psychosis, etc.); or special cases were evaluated by the local experimental center heart team as not suitable for the surgical application of this clinical trial instrument;
19. Participants who have participated in clinical trials of any drug and/or medical device within 1 month before this study;
20. In the judgment of the Investigator, patients were not compliant enough to complete the study as required.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MitralStitch repair system; Experimental group is allocated to use novel mitral vavle repair system manufactured by Hangzhou Valgen Medtech Co., Ltd	Device: MitralStitch; With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial neochordae or ege-to-ege repair using MitralStitch System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The instant procedural success	Technical success is defined as the absence of death, the successful implantation of the device and complete retraction of the delivery system without any need for emergency surgery or secondary intervention (including device related and surgical approach related	Immediately after repair
The success of the repair system	The success rate of the device is defined as the successful delivery and implantation of the device, and the successful withdrawal of the implanted parts after the completion of the release, without any technical failure or complications related to the device.	12 months
The success of the surgery	Surgical success was defined as the success of the instrument, MR 2+, and no major adverse events related to the instrument or operation occurred during the follow-up period after the implantation of the instrument.	1 month
New York Heart Association (NYHA) class	NYHA grading was used to evaluate the cardiac function status of subjects	12 months
Living quality	Postoperative SF-12 was used to evaluate the quality of life of the subjects	12 months
Incidence of major adverse events(MAE)	MAE definition: Any complications related to devices or surgeries, including but not limited to: death, emergency surgery, severe cardiac tamponade requiring pericardiocentesis or operation, hemorrhage, stroke related to operation.	12 months

Collaborators and Investigators

• Sponsor: Hangzhou Valgen Medtech Co., Ltd
• Investigators: Principal Investigator: Shengshou Hu, Chinese Academy of Medical Science, Fuwai hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: August 31, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Mitral Regurgitation; Transapical; Mitral Valve Repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: MIRACLE_II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No