Clinical trial NCT02590679: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pulmonary Regurgitation
Tetralogy of Fallot
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
name: Huaxi Hospital
name: Shanghai Chest Hospital
name: Shanghai Children's Medical Center
First posted: 2015-10-29
Enrollment: 44
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: right ventricular end diastolic volume index
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of adverse cardiovascular events
timeFrame: 48 hours
measure: Incidence of deaths or strokes
timeFrame: 12 months
measure: pulmonary pressure gradient
timeFrame: 1,3,6,12 months
measure: grade of pulmonary regurgitation
timeFrame: 1,3,6,12 months
measure: New York Heart Association (NYHA) class
timeFrame: 1,3,6,12 months
measure: 6 minutes walk distance
timeFrame: 1,3,6,12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hopital of Fudan University
state: Shanghai
city: Beijing
country: China
facility: Beijing Fuwai Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
affiliation: Fudan University
name: Junbo Ge, M.D.
role: STUDY_CHAIR
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.