BridgeMD
New treatment option for Symptomatic Aortic Stenosis
Official title Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System
ClinicalTrials.gov ID: NCT04861805
What this study is testing
- What it's testing
- This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Male or Female
- Age ≥ 65 years at time of consent
- Women of non-childbearing potential
- Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:
- Aortic valve area (AVA) \< 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
You likely can't join if
- Cardiovascular System:
- Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
- Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK...
- Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.
- Patient has a hypertrophic obstructive cardiomyopathy.
- History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation...
See the full eligibility criteria
Who can join
- Male or Female
- Age ≥ 65 years at time of consent
- Women of non-childbearing potential
- Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:
- Aortic valve area (AVA) \< 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
- Jet velocity \> 4.0 m/s or mean gradient \> 40 mmHg
- Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:
- Dyspnea that qualifies at NYHA class II or greater
- Angina pectoris
- Cardiac syncope
- Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:
- EuroSCORE II ≥ 4% along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines
- Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement.
- The local Heart Team deems the patient to be eligible for transfemoral TAVI.
- Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) analyzed by a core lab.
- Adequate iliofemoral access with either:
- At least one side with minimum vessel diameter ≥ 6.0 mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath, as analyzed by a core lab, OR
- At least one side with minimum vessel diameter ≥ 5.5 and no significant calcification or severe tortuosity for safe placement of the introducer sheath, as analyzed by a core lab.
- Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.
- The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
What rules you out
- Cardiovascular System:
- Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
- Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or...
- Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.
- Patient has a hypertrophic obstructive cardiomyopathy.
- History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).
- Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
- Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support
- Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block \>I) at screening and at time of IMD...
- Patient has severe peripheral vascular disease:
- including aortic aneurysm defined as maximal luminal diameter \> 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [\> 5...
- symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.
- Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:
- severe calcification,
- severe tortuosity (\> two 90-degree bends),
- diameter \< 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity
- diameter \< 5.5, in patients with no calcification and no significant tortuosity, OR
- subject has had an aorto-femoral bypass
- Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation.
- Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation.
- Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).
- Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.
- Patient has a need for emergency surgery for any reason at time of screening or IMD implantation. General:
- Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)
- Patient with renal insufficiency (eGFR \ 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening
- Patient with significant pulmonary disease (FEV1 \< 30%) or currently on home oxygen
- Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)
- Patients with evidence of an active systemic infection or sepsis.
- Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin.
- Patient has a haemoglobin \ 700.000 cells/mm3, or white blood cell count \< 1.000 cells/mm3, history of bleeding diathesis or coagulopathy
- Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.
- Patient refuses blood transfusions.
- Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent).
- Patient is pregnant or breast feeding.
- Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from...
- Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams.
- Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).
The study team makes the final eligibility decision.
Where it's taking place
- Bahía Blanca, Argentina
- Buenos Aires, Argentina
- Rio de Janeiro, Rio de Janeiro, Brazil
- São Paulo, São Paulo, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Santiago, Chile
- Talcahuano, Chile
- Bangalore, India
- Gurgaon, India
- Jaipur, India
- Kochi, India
- Vellore, India
- Kaunas, Kaunas County, Lithuania
- Lisbon, Lisbon District, Portugal
- Carnaxide, Portugal
- Vila Nova de Gaia, Portugal
- Evora, Évora District, Portugal
- Barcelona, Barcelona, Spain
- Madrid, Madrid, Spain
+ 5 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bahía Blanca, Argentina; Buenos Aires, Argentina; Rio de Janeiro, Rio de Janeiro, Brazil; São Paulo, São Paulo, Brazil; Rio de Janeiro, Brazil; São Paulo, Brazil and 19 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.