## Protocol Section
### Identification Module
**NCT ID:** NCT02590679

**Acronym:** Venus-P

**Brief Title:** Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p

**Official Title:** Multi-center Trial of Percutaneous Pulmonary Valve Implantation Using Venus-P Valve for Patients With Severe Pulmonary Regurgitation and Native Right Ventricular Outflow Tract After Previous Surgical Repair

#### Organization Study ID Info
**ID:** PPVI-2013
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2017-02

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2015-10-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-10-28

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2016-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-05

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2015-10-29
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-15
**Study First Submit QC Date:** 2015-10-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Fu Wai Hospital, Beijing, China

**Class:** OTHER

**Name:** Huaxi Hospital

**Class:** OTHER

**Name:** Shanghai Chest Hospital

**Class:** OTHER

**Name:** Shanghai Children's Medical Center

#### Lead Sponsor

**Class:** OTHER

**Name:** Shanghai Zhongshan Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and native right ventricular outflow tract (RVOT) after surgical repair of RVOT.

**Detailed Description:** Clinical experience to date with transcatheter pulmonary valve replacement has been limited to two balloon expandable systems, namely the Melody Valve (Medtronic Inc, Minneapolis, MN) and the Sapien valve (Edwards Lifesciences, Irvine, CA). Both valves have undergone clinical trials with good medium-term valve durability. Although both the Melody and the Sapien valves have been used in native outflow tracts with good success , limitations to the extended application of these valves have generally centered on the maximum diameter of the RVOT. Indeed in the majority of patients requiring pulmonary valve replacement (PVR), these balloon expandable systems are not large enough to maintain stable valve position within the dilated native RVOT.Therefore more recent efforts have concentrated on a self-expanding system to provide valve competence despite significant dilation of the native RVOT.

Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the trial is to evaluate the safety and efficacy of the Venus-P Valve for PPVI in patients pulmonary regurgitation and native RVOT after surgical repair of RVOT.

### Conditions Module

**Conditions:**

- Pulmonary Regurgitation

- Tetralogy of Fallot

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 44

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract

**Intervention Names:**

- Device: Venues-P Valve

**Label:** PRAS

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PRAS

**Description:** a Novel Self-Expanding Percutaneous Stent-Valve in the Native Right Ventricular Outflow Tract

**Name:** Venues-P Valve

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** right ventricular end diastolic volume index

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** death, severe arrhythmia, pericardial tamponade, emergency surgery, RVOT rupture, pulmonary artery perforation, cardiac shock, endocarditis, bleeding , and other complications caused by procedure

**Measure:** Incidence of adverse cardiovascular events

**Time Frame:** 48 hours

**Description:** All cause deaths (cardiac death, and non cardiac death) or strokes

**Measure:** Incidence of deaths or strokes

**Time Frame:** 12 months

**Description:** Max pressure gradient (PG)

**Measure:** pulmonary pressure gradient

**Time Frame:** 1,3,6,12 months

**Measure:** grade of pulmonary regurgitation

**Time Frame:** 1,3,6,12 months

**Measure:** New York Heart Association (NYHA) class

**Time Frame:** 1,3,6,12 months

**Measure:** 6 minutes walk distance

**Time Frame:** 1,3,6,12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Moderate to severe pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract obstruction with trans-annulus or RVOT patch;
2. right ventricular diastolic volume index: 130-160 mL/m2 measured by isotopic examination or cardiac MRI measurements;
3. Age: ≥10 years and ≤60 years;
4. Weight ≥18 Kg;
5. Pulmonary annulus : 14- 31 mm;
6. RVOT length ≥20mm ;
7. Signing the informed consent;
8. Any of the following conditions: ① symptomatic, ②progressive RV systolic dysfunction, ③ progressive tricuspid regurgitation (at least moderate), ④ RVOT obstruction with RV systolic pressure ≥80 mmHg, ⑤ Sustained atrial/ventricular arrhythmias.

Exclusion Criteria:

1. Pre-existing pulmonary artery stenosis or artificial pulmonary valve at any position;
2. Severe chest wall deformity (funnel chest, etc.);
3. Acute uncompensated heart failure;
4. Active infection or endocarditis requiring antibiotic therapy;
5. Leukopenia (white blood cell \<3000 mm3);
6. Acute or chronic anemia (hemoglobin \<9 g/L);
7. Platelet counts \<10000 /mm3;
8. Impossibly of delivering Venus-P to RVOT as judged by researcher s before procedure;
9. Known allergy to aspirin or heparin;
10. Positive urine or serum pregnancy test in female subjects.

**Maximum Age:** 60 Years

**Minimum Age:** 10 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** peden@sina.com

**Name:** Wenzhi Pan, M.D.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** peden@sina.com

- **Name:** Wenzhi Pan, M.D.

- **Role:** CONTACT

**Country:** China

**Facility:** Zhongshan Hopital of Fudan University

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200032

**Location 2:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Gejun Zhang, M.D.

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Fuwai Hospital

**Status:** RECRUITING

**Location 3:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Xin Pan, M.D.

- **Role:** CONTACT

**Country:** China

**Facility:** Shanghai Chest Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Fudan University

**Name:** Junbo Ge, M.D.

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Cao QL, Kenny D, Zhou D, Pan W, Guan L, Ge J, Hijazi ZM. Early clinical experience with a novel self-expanding percutaneous stent-valve in the native right ventricular outflow tract. Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1131-7. doi: 10.1002/ccd.25544. Epub 2014 May 28.

**PMID:** 24824357

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006330

- Term: Heart Defects, Congenital

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000000013

- Term: Congenital Abnormalities

- ID: D000006349

- Term: Heart Valve Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16539

- Name: Tetralogy of Fallot

- Relevance: HIGH

- As Found: Tetralogy of Fallot

- ID: M14519

- Name: Pulmonary Valve Insufficiency

- Relevance: HIGH

- As Found: Pulmonary Regurgitation

- ID: M9418

- Name: Heart Defects, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5613

- Name: Tetralogy of Fallot

- Relevance: HIGH

- As Found: Tetralogy of Fallot

### Condition Browse Module - Meshes

- ID: D000013771

- Term: Tetralogy of Fallot

- ID: D000011665

- Term: Pulmonary Valve Insufficiency

### Misc Info Module

- Version Holder: 2024-05-24
