Suspended

Clinical Investigation of the Perceval S Sutureless Heart Valve

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What is being tested

Perceval S Aortic Heart Valve

Device
Who is being recruted

Aortic Valve Disease+4

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorSorin Group USA, Inc.
Last updated: November 16, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve implanted in patients requiring aortic valve replacement. The study will be conducted in a maximum of 25 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, in the late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11 and 13 months postoperatively), and annually until study completion. The duration of the study is anticipated to be 5 years.

NCT01810679
Principal SponsorSorin Group USA, Inc.
Last updated: November 16, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

355 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesVentricular Outflow ObstructionAortic Valve InsufficiencyAortic Valve Stenosis

Criteria

6 inclusion criteria required to participate
Subject will be available to the investigator(s) for postoperative follow-up beyond one year
Subjects of age >= 18 years
Subjects with aortic valve stenosis or steno-insufficiency
The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement
Show More Criteria
15 exclusion criteria prevent from participating
Subject is known to be noncompliant or is unlikely to complete the study
Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass
Subjects with active myocarditis
Subjects with an aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is > 1.3
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Treatment with the Perceval S Aortic Heart Valve

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

East Alabama Medical Center

Opelika, United StatesOpen East Alabama Medical Center in Google Maps

University of Arizona

Tucson, United States

University of Colorado Denver

Aurora, United States

St. Vincent's Medical Center

Jacksonville, United States
Suspended21 Study Centers