## Protocol Section
### Identification Module
**NCT ID:** NCT01810679

**Brief Title:** Perceval S Aortic Heart Valve Study- North America

**Official Title:** Clinical Investigation of the Perceval S Sutureless Heart Valve

#### Organization Study ID Info
**ID:** G120053
#### Organization
**Class:** INDUSTRY
**Full Name:** Sorin Group USA, Inc.
### Status Module
#### Completion Date
**Date:** 2018-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-11-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-15

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Start Date
**Date:** 2013-04

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2013-03-13
**Type:** ESTIMATED
**Study First Submit Date:** 2013-03-07
**Study First Submit QC Date:** 2013-03-11
**Why Stopped:** FDA approval
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sorin Group USA, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Aortic Valve Stenosis

- Aortic Valve Stenosis With Insufficiency

- Regurgitation, Aortic Valve

- Aortic Valve Incompetence

**Keywords:**

- aortic valve replacement

- aortic stenosis

- aortic steno-insufficiency

- Perceval

- Sutureless aortic heart valve

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 355

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment with the Perceval S Aortic Heart Valve

**Intervention Names:**

- Device: Perceval S Aortic Heart Valve

**Label:** Perceval S Aortic Heart Valve

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Perceval S Aortic Heart Valve

**Description:** Perceval S Sutureless Aortic Heart Valve

**Name:** Perceval S Aortic Heart Valve

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life

**Measure:** Supplementary Analyses

**Time Frame:** Discharge

#### Primary Outcomes

**Description:** To demonstrate that the complication and survival rates for the PERCEVAL S valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported for other stented bioprostheses in the literature

**Measure:** Primary Safety Endpoint

**Time Frame:** One-year

**Description:** To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls

**Measure:** Primary Efficacy Endpoint

**Time Frame:** One-year

#### Secondary Outcomes

**Description:** To demonstrate that the hemodynamic performance of the PERCEVAL S valve is comparable to that reported in the literature for other stented aortic bioprostheses

**Measure:** Secondary Efficacy Outcomes

**Time Frame:** One-year

**Description:** To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications

**Measure:** Secondary Efficacy Outcomes

**Time Frame:** One-year

**Description:** To demonstrate that the rate of device technical success for the PERCEVAL S valve is comparable to that of appropriate historical controls

**Measure:** Secondary Efficacy Outcomes

**Time Frame:** One-year

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

1. Subjects of age \>= 18 years.
2. Subjects with aortic valve stenosis or steno-insufficiency.
3. The subject is willing to sign the informed consent.
4. The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
5. The subject is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
6. Subject will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion criteria:

1. The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position.
2. The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
3. The subject has a previously implanted PERCEVAL valve that requires replacement.
4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.
5. The subject has active endocarditis.
6. Subjects with active myocarditis
7. The subject is or will be participating in a concomitant research study of an investigational product.
8. Subjects with aneurysmal dilation or dissection of the ascending aortic wall.
9. The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
10. The 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 patient.
11. Subjects with known hypersensitivity to nickel alloys.
12. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
13. The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
14. Subject is known to be noncompliant or is unlikely to complete the study.
15. 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Opelika

**Country:** United States

**Facility:** East Alabama Medical Center

**State:** Alabama

**Zip:** 36801

**Location 2:**

**City:** Tucson

**Country:** United States

**Facility:** University of Arizona

**State:** Arizona

**Zip:** 85724

**Location 3:**

**City:** Aurora

**Country:** United States

**Facility:** University of Colorado Denver

**State:** Colorado

**Zip:** 80045

**Location 4:**

**City:** Jacksonville

**Country:** United States

**Facility:** St. Vincent's Medical Center

**State:** Florida

**Zip:** 32204

**Location 5:**

**City:** Miami

**Country:** United States

**Facility:** Baptist Cardiac and Vascular Institute

**State:** Florida

**Zip:** 33176

**Location 6:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University

**State:** Georgia

**Zip:** 30308

**Location 7:**

**City:** Indianapolis

**Country:** United States

**Facility:** St. Vincent Heart Center of Indiana

**State:** Indiana

**Zip:** 46290

**Location 8:**

**City:** Portland

**Country:** United States

**Facility:** Maine Medical Center

**State:** Maine

**Zip:** 04102

**Location 9:**

**City:** Baltimore

**Country:** United States

**Facility:** University of Maryland

**State:** Maryland

**Zip:** 21201

**Location 10:**

**City:** Dearborn

**Country:** United States

**Facility:** Oakwood Hospital

**State:** Michigan

**Zip:** 48124

**Location 11:**

**City:** Rochester

**Country:** United States

**Facility:** Mayo Clinic

**State:** Minnesota

**Zip:** 55905

**Location 12:**

**City:** New York

**Country:** United States

**Facility:** New York Presbyterian - Weill Cornell Medical Center

**State:** New York

**Zip:** 10065

**Location 13:**

**City:** New York

**Country:** United States

**Facility:** Montefiore Medical Center/Albert Einstein College of Medicine

**State:** New York

**Zip:** 10467

**Location 14:**

**City:** New York

**Country:** United States

**Facility:** Lenox Hill/NS-LIJ

**State:** New York

**Zip:** 11075

**Location 15:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic

**State:** Ohio

**Zip:** 44195

**Location 16:**

**City:** Toledo

**Country:** United States

**Facility:** ProMedica Toledo Hospital

**State:** Ohio

**Zip:** 43606

**Location 17:**

**City:** Philadelphia

**Country:** United States

**Facility:** University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

**Location 18:**

**City:** Austin

**Country:** United States

**Facility:** Cardiothoracic and Vascluar Surgeons

**State:** Texas

**Zip:** 78756

**Location 19:**

**City:** Charlottesville

**Country:** United States

**Facility:** University of Virginia

**State:** Virginia

**Zip:** 22908

**Location 20:**

**City:** Falls Church

**Country:** United States

**Facility:** Inova Heart and Vascular Institute

**State:** Virginia

**Zip:** 22042

**Location 21:**

**City:** Seattle

**Country:** United States

**Facility:** University of Washington

**State:** Washington

**Zip:** 98195

#### Overall Officials

**Official 1:**

**Affiliation:** The Cleveland Clinic

**Name:** Rakesh Suri, MD, DPhil

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000082862

- Term: Aortic Valve Disease

- ID: D000006349

- Term: Heart Valve Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014694

- Term: Ventricular Outflow Obstruction

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: HIGH

- As Found: Stenosis

- ID: M4338

- Name: Aortic Valve Insufficiency

- Relevance: HIGH

- As Found: Regurgitation, Aortic Valve

- ID: M4340

- Name: Aortic Valve Stenosis

- Relevance: HIGH

- As Found: Aortic Valve Stenosis

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M2379

- Name: Aortic Valve Disease

- Relevance: LOW

- As Found: Unknown

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17440

- Name: Ventricular Outflow Obstruction

- Relevance: LOW

- As Found: Unknown

- ID: T449

- Name: Aortic Valve Stenosis

- Relevance: HIGH

- As Found: Aortic Valve Stenosis

### Condition Browse Module - Meshes

- ID: D000001024

- Term: Aortic Valve Stenosis

- ID: D000001022

- Term: Aortic Valve Insufficiency

- ID: D000003251

- Term: Constriction, Pathologic

### Misc Info Module

- Version Holder: 2024-05-24
