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New treatment option for Tricuspid Regurgitation
Official title Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
ClinicalTrials.gov ID: NCT05434507
What this study is testing
- What it's testing
- Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90
You may be able to join if
- Aged 60 or older, regardless of gender;
- Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);
- The multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. [No. of...
- Patient with normal left ventricular function (LVEF≥40%);
- The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.
You likely can't join if
- Patients with pulmonary artery systolic pressure ≥55 mmHg;
- Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the...
- Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
- Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
- Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- Received PCI less than 1 month ago;
See the full eligibility criteria
- Aged 60 or older, regardless of gender;
- Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);
- The multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. [No. of experts in cardiovascular surgery \>=2]) considers the people to be at high...
- Patient with normal left ventricular function (LVEF≥40%);
- The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.
- Patients with pulmonary artery systolic pressure ≥55 mmHg;
- Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past;
- Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
- Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
- Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- Received PCI less than 1 month ago;
- MI happened or UAP was found less than 1 month ago;
- CVA occurred less than 3 months ago;
- Patients with comorbid active endocarditis or active RHD;
- Patients with coagulation disorder, hypercoagulable state or anemia (HGB \< 90 g/L);
- Patients with acute infection or other severe infections;
- Patients with active peptic ulcer or active gastrointestinal bleeding;
- Patients with severe end-stage diseases (e.g., malignant tumors, severe pulmonary diseases, hepatic diseases, renal failure) whose life expectancy is less than 1 year;
- Patients with known allergies or contraindications to the raw materials of trial product or the drugs (e.g., antiplatelet drugs, anticoagulant drugs);
- People who are addicted to alcohol, drugs or narcotics;
- Patients with cognitive impairment who cannot cooperate with the study or follow-up;
- Those with a history of epilepsy or mental illness;
- Participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form;
- Other situations that the investigator considers inappropriate for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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, 60 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.