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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tetralogy of Fallot; Pulmonary Regurgitation
• Intervention / Treatment: Device: Venues-P Valve

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Wenzhi Pan, M.D.; Email: peden@sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Fuwai Hospital
    • Contact: Gejun Zhang, M.D.
  • Shanghai, China
    • Recruiting
    • Shanghai Chest Hospital
    • Contact: Xin Pan, M.D.
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hopital of Fudan University
      • Contact: Wenzhi Pan, M.D.; Email: peden@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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
Experimental: PRAS; pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract	Device: Venues-P Valve; a Novel Self-Expanding Percutaneous Stent-Valve in the Native Right Ventricular Outflow Tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
right ventricular end diastolic volume index	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of deaths or strokes	All cause deaths (cardiac death, and non cardiac death) or strokes	12 months
pulmonary pressure gradient	Max pressure gradient (PG)	1,3,6,12 months
grade of pulmonary regurgitation		1,3,6,12 months
New York Heart Association (NYHA) class		1,3,6,12 months
6 minutes walk distance		1,3,6,12 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shanghai Children's Medical Center; Shanghai Chest Hospital; Fu Wai Hospital, Beijing, China; Huaxi Hospital
• Investigators: Study Chair: Junbo Ge, M.D., Fudan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Tetralogy of Fallot; Pulmonary Valve Insufficiency
• Other Study ID Numbers: PPVI-2013

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