Mitral RegurgitationNCT04080362
Safety and Performance Study of the MitralStitch Repair System.
A study testing MitralStitch in people with Mitral Regurgitation, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- MitralStitch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2019to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 40mm ≤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.
Who cannot join
- 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;
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- 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；
- Modified Rankin scale ≥4；
- Pregnant or lactating women;
- 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;
- Participants who have participated in clinical trials of any drug and/or medical device within 1 month before this study;
- In the judgment of the Investigator, patients were not compliant enough to complete the study as required.
Trial locations and contacts
1 site in 1 country.
China1 site
Structural Heart Disease Center, Fuwai Hospital
Beijing, Beijing Municipality
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Regurgitation
- Being tested
- MitralStitch
- Keywords
- Mitral Regurgitation, Mitral Valve Repair, Transapical
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitralStitchDevice
With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial neochordae or ege-to-ege repair using MitralStitch System
| Study group | Role | What they receive |
|---|---|---|
| MitralStitch repair system | Experimental | Experimental group is allocated to use novel mitral vavle repair system manufactured by Hangzhou Valgen Medtech Co., Ltd Receives: Device: MitralStitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 1 month
New York Heart Association (NYHA) class
NYHA grading was used to evaluate the cardiac function status of subjects
Measured: 12 months
Living quality
Postoperative SF-12 was used to evaluate the quality of life of the subjects
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start5 Jul 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Valgen Medtech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shengshou Hu, Principal investigator, Chinese Academy of Medical Science, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080362
- Sponsor's protocol ID
- MIRACLE_II
- Status last verified
- May 2019
- First submitted
- 31 Aug 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04080362
- Acronym / sponsor ID
- MIRACLE_II
- Conditions
- Mitral Regurgitation
- Keywords
- Mitral Regurgitation, Mitral Valve Repair, Transapical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hangzhou Valgen Medtech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MitralStitch repair system | Experimental | Device: MitralStitchExperimental group is allocated to use novel mitral vavle repair system manufactured by Hangzhou Valgen Medtech Co., Ltd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- 40mm ≤LVESD≤55 mm; 25% ≤LVEF ≤60%; tolerable for small incision thoracic surgery;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitralStitchWith transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial neochordae or ege-to-ege repair using MitralStitch System | Device | MitralStitch repair system |
Primary outcome
The success rate
Time frame: 1 year
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
6 secondary outcomes
The instant procedural success
Time frame: Immediately after repair
The success of the repair system
Time frame: 12 months
The success of the surgery
Time frame: 1 month
New York Heart Association (NYHA) class
Time frame: 12 months
Living quality
Time frame: 12 months
Incidence of major adverse events(MAE)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengshou Hu principal investigator
Chinese Academy of Medical Science, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitralStitch in people with Mitral Regurgitation, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.