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Tests treatment safety and results for Mitral Regurgitation
Official title Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
ClinicalTrials.gov ID: NCT05655897
What this study is testing
- What it's testing
- To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter clinical trial using objective performance criteria.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who volunteer to participate and sign an informed consent form, understand the purpose of the clinical trial and are able to cooperate...
- An age ≥ 18 years;
- Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days to determine...
- Patients' New York Heart Association (NYHA) cardiac function classification (see Appendix II) in grades II, III, or non-ambulatory grade IV；
- Patients' left ventricular ejection fraction LVEF ≥ 20%;
You likely can't join if
- The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;
- The presence of other severe heart valve diseases requiring surgical intervention;
- Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral...
- inability of the valve clips to hold sufficient active leaflets;
- lack of primary and secondary tendon support in the clamping area;
- significant evidence of calcification in the clamping area;
See the full eligibility criteria
Who can join
- Patients who volunteer to participate and sign an informed consent form, understand the purpose of the clinical trial and are able to cooperate throughout the trial process;
- An age ≥ 18 years;
- Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days to determine the presence of symptomatic moderate-severe or severe degenerative...
- Patients' New York Heart Association (NYHA) cardiac function classification (see Appendix II) in grades II, III, or non-ambulatory grade IV；
- Patients' left ventricular ejection fraction LVEF ≥ 20%;
- Patients considered to be at high surgical risk by the multidisciplinary cardiac team ;
- Patients are anatomically suitable for mitral valve repair and suitable for the device under this study as assessed by the multidisciplinary cardiac team; Elements include, however, are not constrained to the following:
- Mitral valve orifice area ≥ 4.0 cm2;
- Left ventricular end-systolic dimension (LVESD) ≤ 60 mm;
- The primary regurgitant bundle is a non-conjunctive regurgitant bundle and if the secondary regurgitant bundle is present, must be clinically insignificant;
- Transeptal puncture and femoral venipuncture are feasible; The recommended reference criteria for high surgical risk are: an STS score of ≥8 for surgical valve replacement (see Appendix III) or an STS score of ≥6 for...
What rules you out
- The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;
- The presence of other severe heart valve diseases requiring surgical intervention;
- Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral regurgitation by the valve clip. The assessment is based on transesophageal...
- inability of the valve clips to hold sufficient active leaflets;
- lack of primary and secondary tendon support in the clamping area;
- significant evidence of calcification in the clamping area;
- significant fissures in the clamping area;
- Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valve leaflet changes resulting from endocarditis or rheumatic heart disease;
- Severe right ventricular insufficiency (e.g. with symptoms of bilateral lower limb edema with increased jugular venous pressure and hepatomegaly); or pulmonary hypertension (pulmonary artery systolic pressure PASA \> 70...
- Patients who have had an acute coronary syndrome within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization;
- Patients with any cardiovascular intervention, cardiac surgery, cardiac resynchronization therapy (CRT, CRT-D), implantation of a buried cardioverter-defibrillator (ICD), etc. within 30 days; or have planned one of...
- Patients underwent mitral valve surgery or mitral transcatheter valve surgery before, or have a left atrial appendage occluder device inside；
- Patients with end-stage heart failure (ACC/AHA stage D), or after cardiac transplantation, or awaiting cardiac transplantation;
- Patients who are hemodynamically unstable, defined as systolic blood pressure \<90 mmHg without postload-reducing drugs, or in cardiogenic shock; or are requiring intra-aortic balloon counterpulsation, or other...
- Patients requiring emergency or urgent surgery for any reason;
- Patients' femoral vein cannot accommodate a 22F catheter or overlaying ipsilateral deep venous thrombosis, as assessed by the investigator, or are anatomically unsuitable for atrial septum puncture; [13
- Patients with active infection requiring concurrent antibiotic treatment; in the case of temporary disease, antibiotics must be discontinued for at least 14 days before enrollment;
- Patients with a history of any cerebrovascular accident within 30 days; or a severe symptomatic carotid stenosis (carotid ultrasound suggesting \>70% stenosis);
- Modified Rankin Scale score ≥ 4 (see Annex IV);
- Patients with a history of acute peptic ulcer or gastrointestinal bleeding within 3 months;
- Patients with hematological cachexia, including granulocytopenia (WBC \<3 x 109/L), anemia (HB \< 90 g/L), thrombocytopenia (PLT \<50 x 109/L), bleeding disorders, and coagulopathy; or the presence of contraindications...
- Patients with a contraindication to transesophageal echocardiography; or a contraindication to general anesthesia；
- Patients with severe chronic obstructive pulmonary disease (COPD) requiring long-term steroids or continuous home oxygen therapy；
- Patients with severe hepatic or renal insufficiency (ALT, AST, creatinine \> 2 times the upper limit of normal values)；
- Pregnant or lactating women, or those with a birth plan within 12 months；
- Patients with known hypersensitivity to device components or contrast media；
- Patients enrolled in another clinical study and within the follow-up period；
- Patients with a disease that would make the evaluation of treatment difficult (e.g. cancer, infection, severe metabolic disease, psychiatric disease, etc.); or patients with a life expectancy shorter than 12 months；
- Patients whose compliance is assessed by the investigator to be poor and are unable to comply with the follow-up schedule and complete the examination; or other situations in which the investigator considers the issue...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.