NCT02590679

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

3.2 years

First QC Date

October 15, 2015

Last Update Submit

October 28, 2015

Conditions

Pulmonary RegurgitationTetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

  • right ventricular end diastolic volume index

    6 months

Secondary Outcomes (6)

  • Incidence of adverse cardiovascular events

    48 hours

  • Incidence of deaths or strokes

    12 months

  • pulmonary pressure gradient

    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

  • +1 more secondary outcomes

Study Arms (1)

PRAS

EXPERIMENTAL

pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract

Device: Venues-P Valve

Interventions

Venues-P ValveDEVICE

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

PRAS

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Moderate to severe pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract obstruction with trans-annulus or RVOT patch;
  • right ventricular diastolic volume index: 130-160 mL/m2 measured by isotopic examination or cardiac MRI measurements;
  • Age: ≥10 years and ≤60 years;
  • Weight ≥18 Kg;
  • Pulmonary annulus : 14- 31 mm;
  • RVOT length ≥20mm ;
  • Signing the informed consent;
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zhongshan Hopital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Beijing Fuwai Hospital

Beijing, China

RECRUITING

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Related 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.25544. Epub 2014 May 28.

    PMID: 24824357RESULT

MeSH Terms

Conditions

Pulmonary Valve InsufficiencyTetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Junbo Ge, M.D.

    Fudan University

    STUDY CHAIR

Central Study Contacts

Wenzhi Pan, M.D.

CONTACT

peden@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 29, 2015

Study Start

May 1, 2013

Primary Completion

July 1, 2016

Study Completion

February 1, 2017

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

CN(3)