PERCEVAL S Valve Clinical Study for Chinese Registration (PERFECT)

This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve.

The secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease
• Intervention / Treatment: Device: Aortic Valve Replacement with Perceval S sutureless heart valve

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital CAMS&PUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject of age > 60 years.
2. Subject with aortic valve stenosis or steno-insufficiency.
3. Subject has signed the informed consent.
4. Subject in which preoperative evaluation is indicated for the need of native or prosthetic aortic valve replacement via open heart surgery
5. Subject is located in a geographic location that will enable the subject to return to the study site for follow-up examinations (i.e. geographically stable).

Exclusion Criteria:

1. Subject has preexisting valve prosthesis or annuloplasty rings in the mitral, pulmonic or tricuspid position.
2. Subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
3. Subject requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass graft (CABG).
4. Subject has active endocarditis.
5. Subject has active myocarditis
6. Subject has aneurysmal dilation or dissection of the ascending aortic wall.
7. Subject is drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
8. Subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject.
9. Subject with known hypersensitivity to nickel alloys.
10. Subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
11. Subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized for ≥30 days prior to the planned valve implant surgery.
12. Subject is known to be noncompliant or is unlikely to complete the study.
13. Subject with an aortic root enlargement, where the ratio between the diameter of the STJ and the annulus diameter, assessed by TEE, is > 1.3. Or for other anatomical reasons that not suitable for PERCEVAL S per IB.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Aortic Valve Replacement with Perceval S sutureless heart valve; Patient undergoing Aortic Valve Replacement with Perceval S sutureless heart valve

Device: Aortic Valve Replacement with Perceval S sutureless heart valve; Patients will be treated with the PERCEVAL S heart valve (PERCEVAL S valve) which is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The PERCEVAL S 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days)	The primary endpoint includes thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days) per CEC adjudication The number and percentage of subjects with free from thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death will be presented, along with individual component of the success.	at one year

Collaborators and Investigators

• Sponsor: Corcym S.r.l
• Investigators: Study Director: Sara Gaggianesi, Corcym S.r.l

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): September 25, 2020
• Study Completion (Estimated): February 25, 2024

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease
• Other Study ID Numbers: TPS004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No