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A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System (VIVA)

Primary Purpose

Symptomatic Aortic Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vienna Aortic Valve SE System
Sponsored by
P+F Products + Features GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Symptomatic Aortic Stenosis focused on measuring heart disease, aortic valve, SSAS, symptomatic severe aortic stenosis, heart valve

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and Female
  2. Age ≥ 65 years at time of consent
  3. Women of non-childbearing potential
  4. Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:

    1. Aortic valve area (AVA) < 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
    2. Jet velocity > 4.0 m/s or mean gradient > 40 mmHg
  5. Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:

    1. Dyspnea that qualifies at NYHA class II or greater
    2. Angina pectoris
    3. Cardiac syncope
  6. Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:

    1. EuroSCORE II ≥ 4%
    2. Agreement by the Heart Team that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement
  7. The local Heart Team, including at least 1 cardiothoracic surgeon and 1 interventional cardiologist, deems the patient to be eligible for transfemoral TAVI.
  8. Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) performed within 90 days prior to planned implantation
  9. Adequate iliofemoral access with minimum average vessel diameter of ≥ 6.0mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath
  10. The distance from coronary ostia to aortic anulus > 12 mm
  11. Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.
  12. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Cardiovascular System:

  1. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
  2. Evidence of an acute myocardial infarction (MI) ≤ 30 days before the 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 troponin elevation).
  3. Patient has had a cerebrovascular stroke or TIA within the past 90 days before IMD implantation.
  4. Patient has a hypertrophic obstructive cardiomyopathy.
  5. History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to the planned IMD implantation (except for pacemaker implantation which is allowed).
  6. Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
  7. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography within 90 days prior.
  8. Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support
  9. 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 valve implantation.
  10. Patient has severe peripheral vascular disease:

    1. 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 mm], protruding or ulcerated atheroma in the aortic arch) or
    2. symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days before IMD implantation.
  11. Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer [severe calcification, tortuosity (> two 90-degree bends), diameter < 6mm, or subject has had an aorto-femoral bypass]
  12. Patient with active bacterial endocarditis within 6 months of planned IMD
  13. Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation.
  14. Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).
  15. Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.
  16. Patient has a need for emergency surgery for any reason at time of screening and valve implantation.

    General:

  17. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)
  18. Patient with renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/ or renal replacement therapy and/ or has serum creatinine level > 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening
  19. Patient with significant pulmonary disease (FEV1 < 30%) or currently on home oxygen
  20. Severe pulmonary hypertension (e.g., PA systolic pressure / systemic pressure >1 or mean pulmonary pressure > 55 mmHg assessed by echocardiography)
  21. Patients with evidence of an active systemic infection or sepsis
  22. 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.
  23. Patient has a hemoglobin < 9 g/dL, platelet count < 50,000 cells/mm3 or > 700.000 cells/mm3, or white blood cell count < 1.000 cells/mm3, history of bleeding diathesis or coagulopathy
  24. Patient has peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months.
  25. Patient refuses blood transfusions.
  26. 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.
  27. Patient is pregnant or breast feeding.
  28. 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 the procedure or compliance with follow-up visits).
  29. 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
  30. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).

Sites / Locations

  • Hospital of Lithuanian University of Health Sciences Kauno klinikosRecruiting
  • Hospital de Santa Cruz
  • Hospital Santa Maria
  • Hospital Santa Marta
  • Centro Hospitalar de Vila Nova de Gaia
  • Hospital Universitario de Oviedo
  • Hospital Universitario Álvaro CunqueiroRecruiting
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Bellvitge
  • Hospital Universitario Ramón y Cajal
  • University Clinical Hospital of ValladolidRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Vienna Aortic Valve

Arm Description

transcatheter aortic valve implantation (TAVI)

Outcomes

Primary Outcome Measures

Percentage of participants with early safety events
To determine early safety of the Vienna Aortic Valve SE System
All-cause mortality
All-cause mortality within 30 days or during index procedure hospitalization, if the postoperative length of stay is longer than 30 days

Secondary Outcome Measures

overall mortality
evaluate overall mortality of patients treated with the Vienna Aortic Valve SE System concept
general feasibility
evaluate general feasibility of the Vienna Aortic Valve SE System design
safety evaluation
evaluate safety of the Vienna Aortic Valve SE System
clinical and hemodynamic performance
evaluate clinical and hemodynamic performance
peri-procedural death
Incidence of peri-procedural death (to capture intra-procedural events that result in immediate or consequent death ≤72 h post-procedure)
Number of participants with incidence of Valve-related complications
Valve-related complication requiring repeat procedure (transcatheter or surgical heart valve replacement)
Number of participants with incidence of vascular complications
Vascular complications (aortic dissection, perforation, rupture or femoral/iliac artery complications) resulting in interventions (surgical or interventional)
Number of participants with incidence of Coronary artery obstruction requiring intervention
Coronary artery obstruction requiring intervention (Evidence of a new, partial or complete obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure)
Number of participants with incidence of Mitral valve apparatus damage or dysfunction
Mitral valve apparatus damage or dysfunction
Number of participants with Evidence of a new pericardial effusion/ tamponade related to the TAVI procedure
Evidence of a new pericardial effusion/ tamponade related to the TAVI procedure
Number of participants with Incidence of Prosthetic valve endocarditis, thrombosis, mispositioning and/or embolization
Prosthetic valve endocarditis, Prosthetic valve thrombosis, Prosthetic valve mispositioning and/or Prosthetic valve embolization
Number of participants with incidence of Valve-related dysfunction
Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or DVI <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Device success
Device success measured by number of patients who are alive with intended device in place without any additional surgical or interventional procedures related to Vienna Aortic Valve.
Technical success
The percentage of surviving participants with successful access delivery and retrieval fo the device delivery system with correct deployment and positioning of the intended device and no need for additional unplanned surgery or re-intervention related to the device or access procedure.
Number of participants with ventricular septal perforation
Ventricular septal perforation ≤7 days after IMD implantation
Number of patients with Cerebrovascular event
Number of patients with Cerebrovascular event ,like Stroke and Transient ischemic attack (TIA) will be assessed.
Number of participants with Life-threatening bleeding
Life-threatening bleeding (at 30 days, 3 months, 6 months and 1 year post-implantation)
Conduction disturbances requiring permanent pacemaker implantation
Conduction disturbances requiring permanent pacemaker implantation (at 30 days, 3 months, 6 months and 1 year post-implantation)
Acute kidney injury
Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) ≤7 days post IMD implantation
Valve function assessed by transthoracic echocardiography (TTE)
Valve function assessed by transthoracic echocardiography (TTE): a. valve position, morphology, function, and evaluation of the left ventricle (LV) size and function.
Number of participants with all-cause, cardiovascular, and non-cardiovascular mortality
All-cause, cardiovascular, and non-cardiovascular mortality at 3 months, 6months and 1 year
Number of participants who were re-hospitalized for valve-related complications or worsening congestive heart failure
Re-hospitalization for valve-related complications or worsening congestive heart failure (at 30 days, 3 months, 6 months and 1 year post-implantation)
Change in heart failure symptoms as assessed by the New York Heart Association (NYHA) classification
Change in heart failure symptoms from baseline as assessed by the New York Heart Association (NYHA) classification (at 30 days, 3 months, 6 months and 1 year post-implantation) Values: NYHA Class I - IV Expected outcome: from NYHA class II or higher to a lower NYHA class
Change in quality of life as assessed by the Kansas City Cardiomyopathy
Change in quality of life from baseline as assessed by the Kansas City Cardiomyopathy questionnaire (KCCQ) (at 30 days, 3 months, 6 months and 1 year post-implantation) overall summary scores range from 0 to 100 Expected outcome: from a higher score to a smaller score
Change in exercise capacity measured as the 6-minute walk distance (6-MWD)
Change in exercise capacity from baseline measured as the 6-minute walk distance (6-MWD) (at 30 days, 3 months, 6 months and 1 year post-implantation)
Change in number of syncope events
Change in number of syncope events from baseline (at 30 days, 3 months, 6 months and 1 year post-implantation)

Full Information

First Posted
April 20, 2021
Last Updated
September 27, 2022
Sponsor
P+F Products + Features GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04861805
Brief Title
A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System
Acronym
VIVA
Official Title
A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
P+F Products + Features GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, non-randomized, single arm, multicenter, multinational two-stage FIH feasibility followed by pivotal study in symptomatic patients with severe aortic stenosis.
Detailed Description
The study consists of 7 visits spread out across two phases over 1 year. The clinical investigation will end at 30 days post-implantation. The subsequent 3-month, 6-month and 1-year follow-up (FU) visits will thus be considered post-market clinical follow-up (PMCF). The FIH study will start by evaluating the safety and feasibility of the device and study design of the Vienna Aortic Valve SE System in 10 patients with SSAS. The FIH patients must meet all study eligibility criteria. Safety and feasibility assessments for patients in the FIH period will include implantation success, hemodynamic performance and monitoring of adverse events (AEs). Early FIH data (i.e. data from the first 10 patients to have completed visit 3 at hospital discharge) will be provided to the Data and Safety Monitoring Board (DSMB) for review during which study enrollment will be paused. After reviewing the safety results from the FIH study, the DSMB will make a recommendation on whether the study may continue as planned. FIH patients will continue to be followed up for 1 year as per protocol. Data from the 10 FIH patients and the subsequent 75 patients will be analyzed together for the pivotal study endpoints. Upon a decision from the DSMB to proceed with the study, enrolment of patients will resume. The clinical investigation phase comprises 4 visits (V1 to V4). After implantation of the IMD at visit 2, early performance and safety assessment of the device will be performed at 30 days (V4). The post-market surveillance phase comprises 3 visits (V5-V7), extending from 3 months to 1 year post-implantation, to evaluate the long-term safety and performance profile of the device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Aortic Stenosis
Keywords
heart disease, aortic valve, SSAS, symptomatic severe aortic stenosis, heart valve

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, non-randomized, single arm, multicenter, multinational two-stage FIH feasibility followed by pivotal study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vienna Aortic Valve
Arm Type
Other
Arm Description
transcatheter aortic valve implantation (TAVI)
Intervention Type
Device
Intervention Name(s)
Vienna Aortic Valve SE System
Intervention Description
The Vienna Aortic Valve SE System (valve sizes: 23, 26, 29 and 31 mm) is a biological valve system intended to be implanted percutaneously in the aortic valve via the transfemoral route. The device is made of bovine pericardium leaflets and a pericardium fabric skirt sutured on a radiopaque nitinol self-expanding stent system, designed for supra-annular positioning to optimize hemodynamic performance. The Vienna Aortic Valve SE System is repositionable and retrievable allowing a more optimal prosthesis positioning to minimize residual paravalvular regurgitation, atrioventricular conduction block/disturbances, and mitral or coronary compromise. The valve comes already pre-mounted on the delivery system, ready to be used, eliminating the need for assembly and crimping of the device prior to valve implantation.
Primary Outcome Measure Information:
Title
Percentage of participants with early safety events
Description
To determine early safety of the Vienna Aortic Valve SE System
Time Frame
up to 30 days
Title
All-cause mortality
Description
All-cause mortality within 30 days or during index procedure hospitalization, if the postoperative length of stay is longer than 30 days
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
overall mortality
Description
evaluate overall mortality of patients treated with the Vienna Aortic Valve SE System concept
Time Frame
up to 1 year
Title
general feasibility
Description
evaluate general feasibility of the Vienna Aortic Valve SE System design
Time Frame
up to 30 days
Title
safety evaluation
Description
evaluate safety of the Vienna Aortic Valve SE System
Time Frame
up to 1 year
Title
clinical and hemodynamic performance
Description
evaluate clinical and hemodynamic performance
Time Frame
up to 1 year
Title
peri-procedural death
Description
Incidence of peri-procedural death (to capture intra-procedural events that result in immediate or consequent death ≤72 h post-procedure)
Time Frame
from date of implantation until 3 days post procedure
Title
Number of participants with incidence of Valve-related complications
Description
Valve-related complication requiring repeat procedure (transcatheter or surgical heart valve replacement)
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Number of participants with incidence of vascular complications
Description
Vascular complications (aortic dissection, perforation, rupture or femoral/iliac artery complications) resulting in interventions (surgical or interventional)
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Number of participants with incidence of Coronary artery obstruction requiring intervention
Description
Coronary artery obstruction requiring intervention (Evidence of a new, partial or complete obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure)
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Number of participants with incidence of Mitral valve apparatus damage or dysfunction
Description
Mitral valve apparatus damage or dysfunction
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Number of participants with Evidence of a new pericardial effusion/ tamponade related to the TAVI procedure
Description
Evidence of a new pericardial effusion/ tamponade related to the TAVI procedure
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Number of participants with Incidence of Prosthetic valve endocarditis, thrombosis, mispositioning and/or embolization
Description
Prosthetic valve endocarditis, Prosthetic valve thrombosis, Prosthetic valve mispositioning and/or Prosthetic valve embolization
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Number of participants with incidence of Valve-related dysfunction
Description
Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or DVI <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Device success
Description
Device success measured by number of patients who are alive with intended device in place without any additional surgical or interventional procedures related to Vienna Aortic Valve.
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Technical success
Description
The percentage of surviving participants with successful access delivery and retrieval fo the device delivery system with correct deployment and positioning of the intended device and no need for additional unplanned surgery or re-intervention related to the device or access procedure.
Time Frame
from date of implantation until date of discharge (equal to or less than 10 days post-procedure)
Title
Number of participants with ventricular septal perforation
Description
Ventricular septal perforation ≤7 days after IMD implantation
Time Frame
from date of implantation until 7 days post-procedure
Title
Number of patients with Cerebrovascular event
Description
Number of patients with Cerebrovascular event ,like Stroke and Transient ischemic attack (TIA) will be assessed.
Time Frame
up to 1 year
Title
Number of participants with Life-threatening bleeding
Description
Life-threatening bleeding (at 30 days, 3 months, 6 months and 1 year post-implantation)
Time Frame
up to 1 year
Title
Conduction disturbances requiring permanent pacemaker implantation
Description
Conduction disturbances requiring permanent pacemaker implantation (at 30 days, 3 months, 6 months and 1 year post-implantation)
Time Frame
up to 1 year
Title
Acute kidney injury
Description
Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) ≤7 days post IMD implantation
Time Frame
from date of implantation until 7 days post-procedure
Title
Valve function assessed by transthoracic echocardiography (TTE)
Description
Valve function assessed by transthoracic echocardiography (TTE): a. valve position, morphology, function, and evaluation of the left ventricle (LV) size and function.
Time Frame
up to 1 year
Title
Number of participants with all-cause, cardiovascular, and non-cardiovascular mortality
Description
All-cause, cardiovascular, and non-cardiovascular mortality at 3 months, 6months and 1 year
Time Frame
up to 1 year
Title
Number of participants who were re-hospitalized for valve-related complications or worsening congestive heart failure
Description
Re-hospitalization for valve-related complications or worsening congestive heart failure (at 30 days, 3 months, 6 months and 1 year post-implantation)
Time Frame
up to 1 year
Title
Change in heart failure symptoms as assessed by the New York Heart Association (NYHA) classification
Description
Change in heart failure symptoms from baseline as assessed by the New York Heart Association (NYHA) classification (at 30 days, 3 months, 6 months and 1 year post-implantation) Values: NYHA Class I - IV Expected outcome: from NYHA class II or higher to a lower NYHA class
Time Frame
up to 1 year
Title
Change in quality of life as assessed by the Kansas City Cardiomyopathy
Description
Change in quality of life from baseline as assessed by the Kansas City Cardiomyopathy questionnaire (KCCQ) (at 30 days, 3 months, 6 months and 1 year post-implantation) overall summary scores range from 0 to 100 Expected outcome: from a higher score to a smaller score
Time Frame
up to 1 year
Title
Change in exercise capacity measured as the 6-minute walk distance (6-MWD)
Description
Change in exercise capacity from baseline measured as the 6-minute walk distance (6-MWD) (at 30 days, 3 months, 6 months and 1 year post-implantation)
Time Frame
up to 1 year
Title
Change in number of syncope events
Description
Change in number of syncope events from baseline (at 30 days, 3 months, 6 months and 1 year post-implantation)
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and 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% Agreement by the Heart Team that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement The local Heart Team, including at least 1 cardiothoracic surgeon and 1 interventional cardiologist, deems the patient to be eligible for transfemoral TAVI. Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) performed within 90 days prior to planned implantation Adequate iliofemoral access with minimum average vessel diameter of ≥ 6.0mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath The distance from coronary ostia to aortic anulus > 12 mm 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. Exclusion Criteria: Cardiovascular System: Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves. Evidence of an acute myocardial infarction (MI) ≤ 30 days before the 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 troponin elevation). Patient has had a cerebrovascular stroke or TIA within the past 90 days before IMD implantation. Patient has a hypertrophic obstructive cardiomyopathy. History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to the planned 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 within 90 days prior. 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 valve implantation. 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 mm], protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days before IMD implantation. Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer [severe calcification, tortuosity (> two 90-degree bends), diameter < 6mm, or subject has had an aorto-femoral bypass] Patient with active bacterial endocarditis within 6 months of planned IMD 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 and valve 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 < 30 ml/min per the Cockcroft-Gault formula) and/ or renal replacement therapy and/ or has serum creatinine level > 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., PA systolic pressure / systemic pressure >1 or mean pulmonary pressure > 55 mmHg assessed by echocardiography) 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 hemoglobin < 9 g/dL, platelet count < 50,000 cells/mm3 or > 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 past 3 months. 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. 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 the procedure or compliance with follow-up visits). 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Kiss, Dr
Phone
+4369913289414
Email
kkiss@productsandfeatures.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rimantas Benetis, Prof Dr
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose A Baz, Dr
Organizational Affiliation
Hospital Universitario Álvaro Cunqueiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rimantas Benetis, Prof Dr
Email
rimantas.benetis@kaunoklinikos.lt
Facility Name
Hospital de Santa Cruz
City
Lisboa
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joao Brito, Dr.
Facility Name
Hospital Santa Maria
City
Lisboa
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Carrilho Ferreira, Dr.
Facility Name
Hospital Santa Marta
City
Lisboa
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duarte Cacela, Dr.
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova De Gaia
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Melica, Dr.
Facility Name
Hospital Universitario de Oviedo
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
César Morís, Dr
Email
cesarmoris@gmail.com
Facility Name
Hospital Universitario Álvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose A Baz Alonso, Dr
Email
jose.antonio.baz.alonso2@sergas.es
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lluis Asmarats Serra, Dr
Facility Name
Hospital Universitario Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan A Gomez Hospital, Dr
Email
jagomezh@bellvitgehospital.cat
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ángel Sánchez Recalde, Dr.
Email
asrecalde@hotmail.com
Facility Name
University Clinical Hospital of Valladolid
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio J Amat-Santos, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System

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