Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
W.L.Gore & Associates
Age
5–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit
2. Age ≥5 years at the time of informed consent signature.
You may not be if
1. 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).
2. Subjects with previously implanted pacemaker (including defibrillators).
3. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
Clareo Health | Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
