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Stented Biological Valve

Perceval valve for Aortic Valve Disease (PERSIST-AVR Trial)

N/A
Waitlist Available
Led By Theodor Fischlein, MD
Research Sponsored by LivaNova
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has an indication for treatment by valve replacement with a bioprosthesis according to the IFU, through either full sternotomy or mini-sternotomy.
The subject has aortic valve disease that can be treated with a commercially available Perceval valve size, based on preoperative CT-scan.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-operatively
Awards & highlights

PERSIST-AVR Trial Summary

This study is evaluating whether a new type of heart valve can be used in people with aortic stenosis.

Eligible Conditions
  • Aortic Valve Disease
  • Aortic Valve Stenosis
  • Aortic Stenosis

PERSIST-AVR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PERSIST-AVR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Secondary outcome measures
Surgical Times

PERSIST-AVR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PercevalExperimental Treatment1 Intervention
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Group II: other Stented biological valvesActive Control1 Intervention
The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.

Find a Location

Who is running the clinical trial?

LivaNovaLead Sponsor
64 Previous Clinical Trials
31,731 Total Patients Enrolled
2 Trials studying Aortic Valve Disease
2,819 Patients Enrolled for Aortic Valve Disease
Corcym S.r.lLead Sponsor
9 Previous Clinical Trials
7,047 Total Patients Enrolled
3 Trials studying Aortic Valve Disease
2,899 Patients Enrolled for Aortic Valve Disease
Theodor Fischlein, MDPrincipal InvestigatorKlinikum Nurnberg, Nurnberg, Germany

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~102 spots leftby Mar 2025