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New treatment option for Aortic Stenosis
Official title Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients
ClinicalTrials.gov ID: NCT06924151
What this study is testing
- What it's testing
- To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- All study participants must meet the following 1. Severe, calcific aortic stenosis with the following criteria:
- Jet velocity ≥4.0 m/s or mean gradient ≥ 40 mmHg OR
- AVA ≤1.0 cm2 or AVA index ≤ 0.6 cm2/m2 Note: Qualifying TTE must be within 90 days prior to randomization AND 2. NYHA class ≥ II OR Exercisee test...
- The Heart Team agrees that the surgical mortality risk is less than 4% according to STS-PROM. The Heart Team's assessment should include evaluation...
- The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by certified...
You likely can't join if
- Candidates will be excluded from the study if any of the following conditions are present:
- History of cardiovascular surgery or thoracotomy
- Pre-existing other valvular disease, coronary artery disease or aortic disease required intervention Note: interventions for arrhythmia or root...
- Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR.
- Native aortic annulus size unsuitable for sizes the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis.
- Iliofemoral vessel characteristics that whould preclude safe insertion of the introducer sheath.
See the full eligibility criteria
Who can join
- All study participants must meet the following 1. Severe, calcific aortic stenosis with the following criteria:
- Jet velocity ≥4.0 m/s or mean gradient ≥ 40 mmHg OR
- AVA ≤1.0 cm2 or AVA index ≤ 0.6 cm2/m2 Note: Qualifying TTE must be within 90 days prior to randomization AND 2. NYHA class ≥ II OR Exercisee test that demonstrates a limited exercise capacity, abnormal blood pressure...
- The Heart Team agrees that the surgical mortality risk is less than 4% according to STS-PROM. The Heart Team's assessment should include evaluation of overall clinical status and comorbidities that may not be adequately...
- The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by certified review board.
What rules you out
- Candidates will be excluded from the study if any of the following conditions are present:
- History of cardiovascular surgery or thoracotomy
- Pre-existing other valvular disease, coronary artery disease or aortic disease required intervention Note: interventions for arrhythmia or root enlargement are not considered exclusionary.
- Heart Team assessment that chest abnormalities or significant frailty would prevent safe SAVR.
- Native aortic annulus size unsuitable for sizes the currently approved and marketed SAVR or TAVR based on preoperative 3D-CT image analysis.
- Iliofemoral vessel characteristics that whould preclude safe insertion of the introducer sheath.
- Evidence of an acute myocardial infarction or PCI ≤ 30 days before randomization
- Aortic valve is unicuspid
- Severe aortic regurgitation (\>3+)
- Severe mitral regurgitation (\>3+) or ≥ moderate stenosis
- Severe tricuspid regurgitation (\>3+) or ≥ moderate stenosis
- Pre-existing mechanical or bioprosthetic valve in any position.
- Complex coronary artery disease:
- Heart Team assessment that CABG is recommended at the time of SAVR
- Heart Team assessment that optimal revascularization cannot be performed
- Symptomatic carotid or vertebral artery disease or treatment of carotid stenosis within 30 days of randomization
- Leukopenia (WBC \< 3000 cell/mL), Thrombocytopenia (Plt \< 50,000 cell/mL), history of bleeding diathesis or coagulopathy.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
- Hypertrophic cardiomyopathy with obstruction (HOCM)
- Ventricular dysfunction with LVEF \< 30%
- Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
- Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
- Stroke or transient ischemic attack (TIA) within 90 days of randomization
- Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy
- Active bacterial endocarditis within 180 days of randomization
- Severe lung disease (FEV1 \< 50% predicted) or currently on home oxygen
- Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
- History of cirrhosis or active liver disease
- Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation, etc.) that would preclude cannulation and aortotomy for SAVR or safe passage of the delivery...
- Patient refuses blood products.
- BMI \> 50 kg/m2
- Estimated life expectancy \< 24 months.
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication.
- Immobility or significant cognitive impairment that would prevent completion of study procedure.
- Currently participating in an investigational drug or another device study.
- Unsuitable as candidates by the principal investigator or a research associate for other reasons
The study team makes the final eligibility decision.
Where it's taking place
- Nagoya, Aichi-ken, Japan
- Matsudo, Chiba, Japan
- Urayasu, Chiba, Japan
- Fukui-shi, Fukui, Japan
- Fukuoka, Fukuoka, Japan
- Kitakyushu, Fukuoka, Japan
- Kurume, Fukuoka, Japan
- Nishinomiya, Hyōgo, Japan
- Kagoshima, Kagoshima-ken, Japan
- Isehara, Kanagawa, Japan
- Kamakura, Kanagawa, Japan
- Kawasaki, Kanagawa, Japan
- Kochi, Kochi, Japan
- Kumamoto, Kumamoto, Japan
- Matsumoto, Nagano, Japan
- Nagasaki, Nagasaki, Japan
- Niigata, Niigata, Japan
- Okayama, Okayama-ken, Japan
- Tomigusuku, Okinawa, Japan
- Kishiwada, Osaka, Japan
+ 13 more site(s).
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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nagoya, Aichi-ken, Japan; Matsudo, Chiba, Japan; Urayasu, Chiba, Japan; Fukui-shi, Fukui, Japan; Fukuoka, Fukuoka, Japan; Kitakyushu, Fukuoka, Japan and 27 more location(s). 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.