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Not yet recruiting NCT05941455

A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve

No phase Interventional Aortic Valve Disease Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venus-Neo Surgical Aortic Valve.
Who it may be relevant to
Registry conditions: Aortic Valve Disease, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.

Detailed description

This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.

Interventions

  • Device Venus-Neo Surgical Aortic Valve
    Implant of a Venus-Neo Surgical Aortic Valve

Primary outcome measures

  • primary composite safety endpoint [Time frame: 1 year]
Secondary outcome measures (2)
  • secondary composite safety endpoint [Time frame: 2 through 5 Years]
  • Occurrence of each of the following adverse events [Time frame: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Patients who are clinically indicated for aortic valve replacement
  • Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent

Exclusion criteria

  • Previous surgical or/and transcatheter cardiac valve replacement at any site
  • Previous open-heart surgical valve repair at any site
  • Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
  • Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
  • Untreated clinically significant coronary artery diseases requiring revascularization
  • Acute myocardial infarct within the previous 30 days
  • Severe right heart dysfunction
  • Active infection requiring antibiotic therapy including infective endocarditis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Severe symptomatic carotid artery stenosis
  • Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
  • Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis
  • Hematologic disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Hematooncology specialists
  • Severe chronic lung disease
  • Previous organ transplant or currently an organ transplant candidate Anatomical
  • LVEF < 20%
  • Left ventricular end diastolic diameter (LVEDD) >70mm
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Native aortic valve geometry and size unfavorable for study bioprosthetic valve General
  • Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
  • Urgent, emergency or salvage surgeries
  • Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement
  • Life expectancy ≤ 1 year due to non-cardiac reasons
  • Planned relevant concomitant procedure within 30 days post index procedure
  • Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial
  • Pregnant, breastfeeding or intend to become pregnant within 1 year
  • Currently incarcerated or unable to give voluntary informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Deutsches Herzzentrum Berlin-Charité — Berlin

Identifiers

NCT: NCT05941455 · VSAF-23-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗