The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Congenital Heart Disease Clinical Trial

Official title:

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02979587
• Other study ID #: MDT16004CON001
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 2031

Study information

• Verified date: February 2024
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: February 2031
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Pulmonary Regurgitation
• Pulmonary Valve Insufficiency
• RVOT Anomaly
• Tetralogy of Fallot
• Tetrology of Fallot

Intervention

Device:
• Harmony TPV System
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	Ronald Regan UCLA Medical Center	Los Angeles	California
United States	Yale University	New Haven	Connecticut
United States	Stanford University Medical Center	Palo Alto	California
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Heart Valves

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Primary	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%	6 months
Secondary	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	At exit from catheterization lab/operating room (OR)
Secondary	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	5 years
Secondary	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	30 days
Secondary	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)	5 years (5 year data has an anticipated reporting date of April 2025)
Secondary	Assessment of Safety	All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).	Ongoing
Secondary	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.	Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year
Secondary	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).	Baseline, 6 Month
Secondary	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.	4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2025)
Secondary	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).	2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2025)