The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States. The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame. The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience). The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.
Ronald Regan UCLA Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Yale University
New Haven, Connecticut, United States
Freedom From Procedure- or Device-related Mortality at 30 Days.
The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.
Time frame: 30 days
Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
Defined as: * Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND- * Pulmonary regurgitant fraction as measured by magnetic resonance imaging \<20%
Time frame: 6 months
Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)
Technical success at exit from catheterization lab/operating room (OR), as defined as: * No device- or procedural-related mortality, with * Successful access, delivery and retrieval of the delivery system, and * Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and * No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Time frame: At exit from catheterization lab/operating room (OR)
Device Success Out to 5 Years
Device success is defined as: * No device- or procedural-related mortality, with * Original intended device in place, and * No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the catheterization lab), and * Intended performance of the device, as defined as: * Structural performance: No migration, embolization, detachment, major stent fracture, hemolysis, thrombosis, endocarditis, and * Hemodynamic performance: Relief of insufficiency (PR \< moderate) without producing the opposite (mean RVOT gradient \> 40 mmHg) as measured by continuous wave Doppler, and * Absence of para-device complications, as defined by: * PVL = moderate, or * Erosion, or * RVOT or PA rupture
Time frame: 5 years
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Mayo Clinic
Rochester, Minnesota, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada
...and 2 more locations
Number of Participants With Procedural Success at 30 Days
Procedural success is defined as: * Device success at 30 days, and * None of the following device- or procedure-related serious adverse events: * Life-threatening major bleed * Major vascular or cardiac structural complications required unplanned reintervention or surgery * Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis) * Pulmonary embolism * Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support * Prolonged intubation \>48 hours
Time frame: 30 days
Freedom From TPV Dysfunction Out to 5 Years
TPV dysfunction is defined as any one of the following: * RVOT reoperation for device-related reasons * Catheter re-intervention of TPV * Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient \>40 mmHg)
Time frame: 5 years (5 year data has an anticipated reporting date of April 2026)
Assessment of Safety
All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).
Time frame: Ongoing
Characterization of Quality of Life Scores Out to 5 Years
Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted \> 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.
Time frame: Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year
Characterization of Right Ventricle Remodeling Following TPV Implant
Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).
Time frame: Baseline, 6 Month
Characterization of Quality of Life Scores Out to 5 Years
Quality of life score over time will be assessed by the SF-36 at 4 \& 5 years. The analysis cohort will be the implanted \> 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.
Time frame: 4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2026)
Characterization of Right Ventricle Remodeling Following TPV Implant
Right ventricle remodeling will be assessed via CMR at 2 years post- implant and 5 years post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).
Time frame: 2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2026)