Principal Investigator: Robert Gray
Keywords: Cardiac , Transcatheter pulmonary valve , Congenital Heart Disease Department: Pediatric Cardiology
IRB Number: 00097096 Co Investigator: Mary Martin
Specialty: Cardiology, Pediatric Cardiology
Sub Specialties:
Recruitment Status: Active, not recruiting

Contact Information

 

Brief Summary

The primary objective of this study is to demonstrate the safety and effectiveness of the Harmony TPV system as measured by freedom from procedure or device-related mortality at 30 days and percentage of subjects with acceptable hemodynamic function at 6 months. 

The objective of the Harmony TPV Roll-in phase is to confirm the procedural feasibility, hemodynamic performance and safety profile of the Harmony TPV 25 prior to the Harmony TPV 25 becoming available for implant at all sites.  The Roll-in phase is intended to provide Study Proctors familiarity and added expertise in the implant technique for Harmony TPV 25 prior to proctoring all sites in implanting the Harmony TPV 25.

*UPDATE CIP PAS V1 2021*

8.4. Primary Objectives 8.4.1. Device success through 10 years The analysis cohort for device success will be the attempted implant cohort. CEC and core lab echocardiography and CMR data will be used for analysis. The endpoint will be reported as Kaplan-Meier estimate for device failure which will be the opposite of device success. 8.4.2. Freedom from TPV dysfunction through 10 years The analysis cohort for freedom from TPV dysfunction will be the implanted > 24 hours cohort. CEC and core lab echocardiography and CMR data will be used for analysis. The endpoint will be reported as Kaplan-Meier estimate for device failure which will be the opposite of device success. 8.5. Ancillary Objective(s) 8.5.1. Freedom from all-cause mortality through 10 years The analysis cohort for all-cause mortality will be the catheterized cohort. CEC data will be used for analysis. Survival analysis using the Kaplan-Meier method will be used. 8.5.2. Serious device-related adverse events The analysis cohort will be the attempted implanted cohort. CEC data will be used. Adverse events will be analyzed either via survival analysis using the Kaplan-Meier method or summarized by count and percent as appropriate. 8.5.3. Characterize right ventricle remodeling following TPV implant through 10 years Characterization of right ventricle remodeling following TPV implant via CMR core lab assessments which are performed at 6 months, 2 years, 5 years and 10 years. The analysis cohort will be the implanted > 24 hours cohort. Summary statistics such as mean, standard deviation, minimum, median, and maximum will be provided. 8.5.4. Characterize quality of life scores over time through 10 years Quality of life score over time will be assessed by the SF-36 annually through 10 years. The analysis cohort will be the implanted > 24 hours cohort. Summary statistics such as mean, standard deviation, minimum, median, and maximum will be provided for quality of life scores. 8.5.5. Freedom from reoperation through 10 years The analysis cohort for reoperation will be the attempted implant cohort. CEC data will be used for analysis. Survival analysis using the Kaplan-Meier method will be used. The observed rates through 10 years will be evaluated with reported surgical data via historical literature. There will be no hypothesis testing between TPV and surgical data

Inclusion Criteria

Inclusion Criteria:

Participant has pulmonary regurgitation as per one or more of the following criteria:

  • Severe pulmonary regurgitation as measured by Doppler echocardiography, or
  • Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging

Clinical indication for surgical placement of a RV-PA conduit or prosthetic pulmonary valve per one or more of the following criteria:

  • Participant is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the investigator, or
  • Right ventricular end diastolic volume index (RVEDVi) ≥ 150 ml/m2, or
  • Participant has RVEDV: LVEDV Ratio ≥ 2.0

Participant is willing to consent to participate in the study and will commit to completion of all followup requirements

*UPDATE CIP PAS V1 2021*

Inclusion Criteria • Current participant in Harmony Pivotal Study or Harmony Pivotal Continued Access Study

Exclusion Criteria

Exclusion Criteria:

  • Anatomy unable to accommodate a 25 Fr delivery system
  • Obstruction of the central veins
  • Clinical or biological signs of infection including active endocarditis
  • Planned concomitant procedure at time of Harmony™ TPV implant
  • Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female particpants of child bearing potential
  • Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with a RV-PA conduit implant
  • A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
  • Planned implantation of the Harmony™ TPV in the left heart
  • RVOT anatomy or morphology that is unfavorable for device anchoring
  • Known allergy to aspirin, heparin, or nickel
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Pre-existing prosthetic heart valve or prosthetic ring in any position

 

*UPDATE CIP PAS V1 2021*

Exclusion Criteria • Subject unwilling to commit to completion of remaining follow-up requirement