Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p

Tetralogy of Fallot Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02590679
• Other study ID #: PPVI-2013
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 15, 2015
• Last updated: October 28, 2015
• Start date: May 2013
• Est. completion date: February 2017

Study information

• Verified date: October 2015
• Source: Shanghai Zhongshan Hospital
• Contact: Wenzhi Pan, M.D.
• Email: peden[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: February 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 60 Years

Eligibility

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: ? symptomatic, ?progressive RV systolic dysfunction, ? progressive tricuspid regurgitation (at least moderate), ? RVOT obstruction with RV systolic pressure =80 mmHg, ? 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Regurgitation
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Tetralogy of Fallot

Intervention

Device:
• Venues-P Valve
a Novel Self-Expanding Percutaneous Stent-Valve in the Native Right Ventricular Outflow Tract

Locations

Country	Name	City	State
China	Beijing Fuwai Hospital	Beijing
China	Shanghai Chest Hospital	Shanghai
China	Zhongshan Hopital of Fudan University	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Fu Wai Hospital, Beijing, China, Huaxi Hospital, Shanghai Chest Hospital, Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (1)

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.25 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	right ventricular end diastolic volume index		6 months	No
Secondary	Incidence of adverse cardiovascular events	death, severe arrhythmia, pericardial tamponade, emergency surgery, RVOT rupture, pulmonary artery perforation, cardiac shock, endocarditis, bleeding , and other complications caused by procedure	48 hours	Yes
Secondary	Incidence of deaths or strokes	All cause deaths (cardiac death, and non cardiac death) or strokes	12 months	Yes
Secondary	pulmonary pressure gradient	Max pressure gradient (PG)	1,3,6,12 months	No
Secondary	grade of pulmonary regurgitation		1,3,6,12 months
Secondary	New York Heart Association (NYHA) class		1,3,6,12 months
Secondary	6 minutes walk distance		1,3,6,12 months