Trial Search Results

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Medtronic Heart Valves

Stanford Investigator(s):

Intervention(s):

  • Device: Harmony TPV System

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR
   determined PR fraction >/= 30%

   - Subject has clinical indication for surgical placement of an RV-PA conduit or
   bioprosthetic pulmonary valve

   - Subject is willing to consent to participate

Exclusion Criteria:

   - Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically
   treated with an RV-to-PA conduit implant

   - RVOT anatomy or morphology that is unfavorable for device anchoring

   - Positive pregnancy test

   - Life expectancy of less than 1 year

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting