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Perceval S Aortic Heart Valve Study- North America

NCT01810679 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2016-11-16

No results posted yet for this study

Summary

To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Stenosis With Insufficiency
  • Regurgitation, Aortic Valve
  • Aortic Valve Incompetence

Interventions

DEVICE

Perceval S Aortic Heart Valve

Perceval S Sutureless Aortic Heart Valve

Sponsors & Collaborators

  • Sorin Group USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Rakesh Suri, MD, DPhil · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-02-29
Completion
2018-04-30

Countries

  • United States

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 NCT01810679 on ClinicalTrials.gov