Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

W.L. Gore & Associates logo

W.L. Gore & Associates

Status

Active, not recruiting

Conditions

Heart Defects, Congenital
Tetralogy of Fallot
Pulmonary Valve Stenosis
Pulmonary Valve Insufficiency

Treatments

Device: GORE PV1

Study type

Interventional

Funder types

Industry

Identifiers

NCT03441971
Gore PVC 17-02

Details and patient eligibility

About

This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).

Enrollment

15 estimated patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit
  • Age ≥5 years at the time of informed consent signature.

Note: Additional Inclusion Criteria may apply

Exclusion criteria

  • An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years).
  • Subjects with previously implanted pacemaker (including defibrillators).
  • Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.

Note: Additional Exclusion Criteria may apply

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Single Arm
Experimental group
Description:
Participants will receive the device on Day 1.
Treatment:
Device: GORE PV1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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