Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts

NCT02846753 | Unknown DMC

• 1 other identifier: VMT-001CE
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.

Conditions

Pulmonary Regurgitation

Outcome Measures

Primary Outcomes (7)

• Safety of Venus P-Valve™ measured as probability of death/reoperation

  Occurrence of death or reoperation (Valve and/or procedure related) calculated as a composite freedom-of-death and -reoperation probability at 12 months. The acceptance criterion for mortality and reoperation is 16% (or equivalently 84% freedom from death and reoperation). If the lower 95% confidence limit for survival and freedom from reoperation at 12 months is greater than 84%, the acceptance criterion for safety will have been met.

  month 12 follow-up

• Safety of Venus P-Valve™ measured as probability of Major Adverse Cardiac and Cerebro-vascular Event (MACCE)

  Occurrence of MACCE (defined as death, myocardial infarction, reoperation, vascular injury resulting in the need for an unplanned vascular grafting intervention, stroke, and pulmonary embolism) calculated as freedom-from-MACCE probability at month-1, calculated using the Kaplan Meier method

  month 1 follow-up

• Performance of Venus P-Valve™ measured as Success rate of valve placement and implantation

  The device success is defined as the percentage of subjects with successful implant of the P-Valve assessed at the earliest evaluable echocardiogram. Linearized rates will be presented.

  up to 30 days

• Hemodynamic Performance of Venus P-Valve™ measured as the mean transvalvular pressure (mmHg)

  Hemodynamic performance, measured as the mean transvalvular pressure gradient measured by transthoracic echocardiogram at month-1

  1 month

• Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by MRI)

  Improvement or abolition of pulmonary regurgitation assessed by MRI at baseline and month 6, with grading of pulmonary stenosis defined as: mild \<2, moderate: 2-4; severe \>4

  baseline and month 6

• Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram)

  Improvement or abolition of pulmonary regurgitation assessed by transthoracic echocardiogram at baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure, with grading of pulmonary stenosis defined as: mild \<2, moderate: 2-4; severe \>4

  baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure

• Performance of Venus P-Valve™ measured as percentage of subjects with structural valve deterioration

  Structural valve deterioration assessment includes stent fracture, leaflet mobility, thickening and calcification

  month 6

Secondary Outcomes (3)

• Safety measured as percentage of subjects experiencing serious adverse events

  up to third year of follow-up

• Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram )

  1 month

• Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by MRI)

  month 6

Study Arms (1)

Implantation of Venus P-Valve™

EXPERIMENTAL

Implantation of the Venus P-Valve™ in the pulmonic position in patients with native outflow tracts; trans catheter heart valve replacement.

Procedure: trans catheter heart valve replacement

Interventions

trans catheter heart valve replacement PROCEDURE

trans catheter heart valve replacement

Implantation of Venus P-Valve™

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: range from 12-70 years of age
• Weight must be "equal to" or exceed 30 kilograms
• Subject presents with evidence of moderate or severe (≥3+) pulmonary regurgitation by TTE
• Subject presents with \>30% pulmonary regurgitation fraction as defined by cardiac MRI
• Subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention: right ventricular ejection fraction (RVEF) \< 45%, pulmonary regurgitant fraction (PRRF) \>30% and increased right ventricular end-diastolic volume (RVEDV) \>150ml/m2
• Subject will comply with specified follow-up evaluations, including echocardiograms and MRI
• The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee and regulatory authority if applicable of the respective clinical site
• The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits
• Catheterization is determined to be feasible by the treating physician

You may not qualify if:

• Candidates will be excluded from the study if any of the following conditions are present:
• Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
• Severe chest wall deformity
• Leukopenia (WBC\<3000 mm3)
• Acute or chronic anemia (Hb \<90g/l)
• Platelet count \<100,000 cells/mm3
• In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
• Need for emergency cardiac or vascular surgery, including pulmonary embolectomy, for any reason
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• History of, or active, endocarditis, unless the endocarditis has been treated \>6 months previous to the procedure
• History of or current intravenous drug abuse
• A known hypersensitivity to aspirin or heparin
• Currently participating in an investigational drug or another device study \[Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.\]
• Major or progressive non-cardiac disease resulting in a life expectancy of \<1yr
• Obstruction of the central veins preventing advancement of the pulmonary bioprosthesis delivery system to the heart

Sponsors & Collaborators

• Venus MedTech (HangZhou) Inc.: lead
• IQVIA Inc.: collaborator
• TheraGenesis: collaborator
• Intrials: collaborator

MeSH Terms

Conditions

Pulmonary Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Shakeel A. Qureshi, MD

  Evelina Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: July 27, 2016
• Study Start: August 17, 2016
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share