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

NCT05941455 | Not Yet Recruiting DMC

• 1 other identifier: VSAF-23-02
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Valve Disease; Cardiovascular Diseases

Keywords

Heart Failure; Surgical Cardiovascular Devices

Outcome Measures

Primary Outcomes (1)

• primary composite safety endpoint

  composite safety endpoint at 1 year, including: valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, major paravalvular leak (defined as moderate or greater paravalvular leak or any paravalvular leak requiring intervention), valve thrombosis, endocarditis

  1 year

Secondary Outcomes (2)

• secondary composite safety endpoint

  2 through 5 Years

• Occurrence of each of the following adverse events

  baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter

Other Outcomes (3)

• Clinically acceptable bioprosthetic valve performance

  baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter

• Procedure success

  pre-discharge

• New York Heart Association (NYHA) classification

  baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter

Study Arms (1)

Venus-Neo group

EXPERIMENTAL

Procedure: surgical aortic valve replacement

Device: Venus-Neo Surgical Aortic Valve

Interventions

Venus-Neo Surgical Aortic Valve DEVICE

Implant of a Venus-Neo Surgical Aortic Valve

Venus-Neo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jilin Venus Haoyue Medtech Limited: lead

Study Sites (1)

Deutsches Herzzentrum Berlin-Charité

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Aortic Valve Disease; Cardiovascular Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases

Study Officials

• Volkmar Falk

  Deutsches Herzzentrum Berlin-Charité

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Destino

CONTACT

+493045932260; nadia.destino@dhzc-charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: October 31, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2029
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)