Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

ConditionSymptomatic Aortic Stenosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorP+F Products + Features GmbH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female

Age ≥ 65 years at time of consent

Women of non-childbearing potential

Aortic valve area (AVA) < 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and

Disqualifiers

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 troponin elevation).

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.

Trial design

Design model

Single group

Treatments tested in this trial

Vienna Aortic Valve SE System
Device
Vienna Aortic Valve SE system for TAVI.

Treatment groups

267 Participants

are divided into 1 treatment group

Group A: Vienna Aortic ValveOther 1 intervention

Trial outcomes

Primary outcomes

All Cause Mortality (30 days)

All-cause mortality at 30 days from the index procedure.

Time frame

up to 30 days

Secondary outcomes

All-cause, cardiovascular and non-cardiovascular mortality

All-cause, cardiovascular and non-cardiovascular mortality at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation.

Time frame

up to 5 years

Periprocedural death

Incidence of peri-procedural death (to capture intra-procedural events that result in immediate or consequent death ≤72 h post-procedure)

Time frame

72 hours

Incidence of TAVI-related complications

Incidence of TAVI-related complications: 1. Valve-related complication requiring repeat procedure 2. Vascular complications resulting in interventions 3. Ventricular septal perforation ≤7 days after IMD implantation 4. Acute kidney injury-Stage 2 or 3 ≤7 days post IMD implantation 5. Coronary artery obstruction requiring intervention 6. Atrio-ventricular block requiring pacemaker implantation 7. Mitral valve apparatus damage or dysfunction 8. Evidence of a new pericardial effusion/ tamponade related to the TAVI procedure 9. Prosthetic valve endocarditis 10. Prosthetic valve thrombosis 11. Prosthetic valve mispositioning 12. Prosthetic valve embolization 13. Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or DVI peak velocity \>0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)

Time frame

periprocedural and during index hospitalization

Cerebrovascular event

Cerebrovascular event (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation): 1. Stroke, defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction 2. Transient ischemic attack (TIA), defined as a transient episode of focal neurological dysfunction caused by the brain, spinal cord, or retinal ischemia, without acute infarction. The difference between TIA and ischemic stroke is the presence of tissue damage on neuro-imaging studies or new sensory-motor deficit persisting \>24 h. By definition, a TIA does not produce a lasting disability.

Time frame

Up to 5 years