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

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ClinicalTrials.gov Identifier: NCT02590679
Recruitment Status : Unknown
Verified October 2015 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : October 29, 2015
Last Update Posted : October 29, 2015
Sponsor:
Collaborators:
Fu Wai Hospital, Beijing, China
Huaxi Hospital
Shanghai Chest Hospital
Shanghai Children's Medical Center
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Pulmonary Regurgitation Tetralogy of Fallot Device: Venues-P Valve Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. right ventricular end diastolic volume index [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence of adverse cardiovascular events [ Time Frame: 48 hours ]
    death, severe arrhythmia, pericardial tamponade, emergency surgery, RVOT rupture, pulmonary artery perforation, cardiac shock, endocarditis, bleeding , and other complications caused by procedure

  2. Incidence of deaths or strokes [ Time Frame: 12 months ]
    All cause deaths (cardiac death, and non cardiac death) or strokes

  3. pulmonary pressure gradient [ Time Frame: 1,3,6,12 months ]
    Max pressure gradient (PG)

  4. grade of pulmonary regurgitation [ Time Frame: 1,3,6,12 months ]
  5. New York Heart Association (NYHA) class [ Time Frame: 1,3,6,12 months ]
  6. 6 minutes walk distance [ Time Frame: 1,3,6,12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590679


Contacts
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Contact: Wenzhi Pan, M.D. peden@sina.com

Locations
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China, Shanghai
Zhongshan Hopital of Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Wenzhi Pan, M.D.       peden@sina.com   
China
Beijing Fuwai Hospital Recruiting
Beijing, China
Contact: Gejun Zhang, M.D.         
Shanghai Chest Hospital Recruiting
Shanghai, China
Contact: Xin Pan, M.D.         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Fu Wai Hospital, Beijing, China
Huaxi Hospital
Shanghai Chest Hospital
Shanghai Children's Medical Center
Investigators
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Study Chair: Junbo Ge, M.D. Fudan University

Publications of Results:
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02590679     History of Changes
Other Study ID Numbers: PPVI-2013
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Respiratory Insufficiency
Tetralogy of Fallot
Pulmonary Valve Insufficiency
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Valve Diseases
Respiration Disorders
Respiratory Tract Diseases