Actively Recruiting
Early Feasibility Study of the Pivot Extend Device for Tricuspid Regurgitation Treatment (SPACER Study)
Led by Tau-MEDICAL Co., Ltd. · Updated on 2025-04-11
7
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial evaluates the safety and effectiveness of the investigational "Pivot Extend" medical device for treating severe and symptomatic tricuspid regurgitation (TR). The study aims to monitor major adverse cardiac events (MACEs) and assess device and procedural success along with clinical outcomes over the long term in patients experiencing significant TR symptoms despite medical therapy. Participants will receive the Pivot Extend device, implanted via a transcatheter procedure guided by imaging. After implantation, participants stay under close observation for at least 24 hours to monitor vital signs and device stability. The device is intended for permanent placement with follow-up visits scheduled over a 12-month period to evaluate safety and clinical progress. Device removal may occur if adverse events arise or if the investigator deems it necessary. During the study, participants will attend scheduled visits at 1, 6, and 12 months after the procedure to assess clinical outcomes and procedural success. Researchers will collect data on heart function, symptoms, and any major cardiac events. Safety monitoring includes continuous observation initially post-implant and ongoing evaluation at follow-up visits. The total participation lasts at least one year, with detailed assessments to understand the device's impact on TR symptoms and patient health.
CONDITIONS
Brief Title
Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at screening
- Symptoms despite medical therapy for tricuspid regurgitation for at least 1 month
- Severe (grade 3+) or worse tricuspid regurgitation confirmed by echocardiography
- New York Heart Association (NYHA) class 2 or worse symptoms
- Suitable for percutaneous valve intervention by a Heart Team including cardiologist, cardiac surgeon, and anesthesiologist
- Provided written informed consent voluntarily
- Able to understand and follow study instructions and participate for entire study duration
You will not qualify if you...
- Blood clots, emboli, masses, or growths in heart or lung vessels
- Uncorrected blood clotting disorders
- Unable to use anticoagulant medications
- History of major bleeding treated with anticoagulants
- Severe anemia (hemoglobin 60;10g/dL) requiring hospitalization
- Presence of implantable cardioverter defibrillator or pacemaker
- Anatomy unsuitable for device implantation
- Need for surgery or interventional procedures like CABG or ASD repair
- Platelet count 80,000/uL or less
- Pulmonary arterial hypertension with TR Vmax >3.5 m/s or pulmonary vascular resistance >3 Wood Units
- Left ventricular ejection fraction less than 50%
- Recent active gastrointestinal bleeding or digestive procedures within 3 months
- Stroke or transient ischemic attack within 30 days
- Myocardial infarction within 30 days
- Active endocarditis requiring antibiotics
- Malignancy, end-stage renal failure requiring dialysis, or other conditions limiting life expectancy to less than one year
- Moderate or severe aortic, pulmonary artery, or mitral stenosis
- Moderate or worse mitral valve regurgitation or severe aortic valve regurgitation
- Calcification of tricuspid valve lobes affecting procedure
- Participation in another clinical trial within 30 days
- Pregnant, nursing, or planning pregnancy during trial
- Women of childbearing potential not using medically accepted birth control
- Coexisting condition limiting life expectancy to less than one year
- Preexisting pulmonary valve prosthesis or RV to PA conduit
- Other medical findings deemed inappropriate for trial participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of the Pivot Extend Tricuspid Regurgitation Spacer Device via a transcatheter procedure under imaging guidance.
1 visit (in-person)
Duration - At least 24 hours
Participants are monitored in a specialized facility for at least 24 hours with real-time observation of vital signs following device implantation.
Continuous monitoring during hospital stay
Duration - 12 months
Participants attend scheduled visits over 12 months to assess the safety and efficacy of the implanted device and monitor clinical progress.
Visits at 1 month, 6 months, and 12 months post-procedure
Trial Site Locations
Total: 3 locations
1
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, K'alak'i T'bilisi, Georgia, 0102
Actively Recruiting
2
Tbilisi Heart and Vascular Clinic
Tbilisi, K'alak'i T'bilisi, Georgia, 0159
Actively Recruiting
3
Tbilisi Heart Center
Tbilisi, K'alak'i T'bilisi, Georgia, 0186
Actively Recruiting
Research Team
M
Markus Reinthaler, MD, PhD
S
Seung-Whan Lee, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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