Early Feasibility Study (EFS) of the 'Pivot Extend'
in Treatment for Tricuspid Regurgitation
(SPACER study)
Early Feasibility Study (EFS) of the 'Pivot Extend'
in Treatment for Tricuspid Regurgitation
(SPACER study)
Matsumoto Takashi
Shonan Kamakura General Hospital
1-1370 Okamoto, Kamakura-Shi, Kanagawa
+81-467-46-1717
t_matsumoto_1981@hotmail.co.jp
Matsumoto Takashi
Shonan Kamakura General Hospital
1-1370 Okamoto, Kamakura-Shi, Kanagawa
+81-467-46-1717
t_matsumoto_1981@hotmail.co.jp
Recruiting
July. 16, 2026
Aug. 04, 2026
20
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
Those who meet all of the following criteria are eligible to participate in the clinical trial.
1.Male or female aged 18 years or older at the time of screening
2.Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR for at least 30 days at screening
3.Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit
4.Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse
5.Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one imaging specialist.
6.Those who have voluntarily decided to participate in this clinical trial and have provided personally written informed consent
7.Those who can understand and follow the investigator's instructions and are able to participate for the entire duration of the study
Those who meet any of the following criteria are excluded from this clinical trial.
1.Those with blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at the screening visit
2.Those with uncorrected blood clotting disorders based on laboratory test performed at the screening visit
3.Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)
4. Those who have had major bleeding (not including minor bleeding, such as a nosebleed that can be hemostasized) treated with anticoagulants prior to participation in this clinical trial
5.Those with severe anemia (hemoglobin <=8g/dL)
6.Those who have an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker prior to participation in this clinical trial
7.Those whose anatomy, in the opinion of the investigator, is not suitable for implantation of an investigational medical device based on echocardiogram and cardiac CT scan performed at the screening visit (results from tests performed within 8 weeks of the screening visit can be used)
8. Those who require surgery or interventional procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogram performed at the screening visit
9.Those with a platelet count of 80,000/uL or less based on laboratory test performed at the screening visit
10.Patients with pulmonary arterial hypertension with a TR Vmax greater than 3.5 m/s on echocardiography performed at the screening visit or a pulmonary vascular resistance of more than 3 Wood Units on right heart catheterization
11.Those with a left ventricular ejection fraction (LVEF) of less than 50% on echocardiogram performed at the screening visit
12.Those who have had active gastrointestinal bleeding or a digestive procedure within 90 days prior to the date of informed consent (those with the potential for gastrointestinal bleeding)
13.Those with a history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to the date of informed consent
14.Those with a history of myocardial infarction (MI) within 30 days prior to the date of informed consent
15.Those with active endocarditis requiring antibiotic treatment
16.Those with malignancies with end-stage renal failure requiring hemodialysis and other chronic conditions who have a life expectancy of less than two years
17.Those with moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit
18.Those with moderate or worse mitral valve regurgitation or severe aortic valve regurgitation on the echocardiogram performed at the screening visit
19.Those with calcification of the tricuspid valve lobes affecting the procedure on an echocardiogram performed at the screening visit
20.Those who have participated in another clinical trial within 30 days prior to the date of informed consent or plan to participate in other clinical trials in the near future
21.Pregnant or nursing women, or women planning to become pregnant during the clinical trial period
22.Women of childbearing potential who are not using a medically accepted birth control method*
Medically accepted birth control method: 1 Hormonal contraceptives, 2 implantation of an intrauterine device or intrauterine system, 3 dual contraceptive method [using both a male condom and a barrier cap (contraceptive septum or cervical cap), and 4 sterilization procedures (vasectomy, bilateral tubal ligation, etc.)
23.Those with a coexisting condition, which most likely limits the participant's life expectancy to less than two years
24.Those with a preexisting pulmonary valve prosthesis or RV to PA conduit
25.Those who are clinically and anatomically suitable for treatment of the target condition with an approved tricuspid transcatheter edge-to-edge repair (TEER) device (e.g., TriClip)
26.Those with clinical findings other than the above that, in the opinion of the investigator, are medically inappropriate for this clinical trial
18age old over
No limit
Both
Tricuspid Regurgitation
As part of this clinical study, a long-term implantation procedure using the investigational medical device "Pivot Extend" will be performed. In addition to standard clinical care, assessments related to the safety and efficacy of the device will be conducted over a 12-month follow-up period.
To evaluate the patient's quality of life (QOL), the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) will be administered.
Determine the safety of long-term implantation of the investigational medical device Pivot Extend by monitoring for major adverse cardiac events MACEs associated with the investigational medical device or procedure that may occur with long-term associated with the investigational medical device or procedure that may occur with long-term implantation.
1 Incidence of MACEs at 1 month
Evaluate device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device ""Pivot Extend"" to determine stabilization and clinical and anatomic changes following reduction of TR.
1)Device Success
2)Procedural Success
3)Clinical Outcomes
