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Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

NCT02673697 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 914

Last updated 2024-03-06

Study results available
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Summary

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study.

The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

Conditions

  • Aortic Valve Disease
  • Aortic Stenosis

Interventions

DEVICE

Perceval valve

Sutureless Aortic Biological Valve

DEVICE

other stented biological valve

Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)

Sponsors & Collaborators

  • Corcym S.r.l

    lead INDUSTRY

Principal Investigators

  • Theodor Fischlein, MD · Klinikum Nurnberg, Nurnberg, Germany

  • Roberto Lorusso, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2020-01-17
Completion
2020-07-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Chile
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02673697 on ClinicalTrials.gov