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The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02979587
Recruitment Status : Active, not recruiting
First Posted : December 1, 2016
Results First Posted : December 2, 2021
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Heart Valves )

Study Description
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Brief Summary:
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Tetrology of Fallot RVOT Anomaly Pulmonary Regurgitation Device: Harmony TPV System Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 17, 2020
Estimated Study Completion Date : January 2031

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Harmony TPV System
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Freedom From Procedure- or Device-related Mortality at 30 Days. [ Time Frame: 30 days ]
    The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.

  2. Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months [ Time Frame: 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%


Secondary Outcome Measures :
  1. Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR) [ Time Frame: 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

  2. Device Success Out to 5 Years [ Time Frame: 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

  3. Number of Participants With Procedural Success at 30 Days [ Time Frame: 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

  4. Freedom From TPV Dysfunction Out to 5 Years [ Time Frame: 5 years (5 year data has an anticipated reporting date of April 2025) ]

    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. Assessment of Safety [ Time Frame: Ongoing ]
    All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).

  6. Characterization of Quality of Life Scores Out to 5 Years [ Time Frame: Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year ]
    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.

  7. Characterization of Right Ventricle Remodeling Following TPV Implant [ Time Frame: Baseline, 6 Month ]
    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).

  8. Characterization of Quality of Life Scores Out to 5 Years [ Time Frame: 4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2025) ]
    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.

  9. Characterization of Right Ventricle Remodeling Following TPV Implant [ Time Frame: 2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2025) ]
    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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979587


Locations
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United States, California
Ronald Regan UCLA Medical Center
Los Angeles, California, United States, 90095
Stanford University Medical Center
Palo Alto, California, United States, 94304
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43215
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Canada, Ontario
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada, M5G 1X8
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Sponsors and Collaborators
Medtronic Heart Valves
Investigators
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Principal Investigator: John P Cheatham, MD Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiovascular ( Medtronic Heart Valves ):
Study Protocol  [PDF] June 12, 2019
Statistical Analysis Plan  [PDF] September 30, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Heart Valves
ClinicalTrials.gov Identifier: NCT02979587    
Other Study ID Numbers: MDT16004CON001
First Posted: December 1, 2016    Key Record Dates
Results First Posted: December 2, 2021
Last Update Posted: January 30, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Pulmonary Valve Insufficiency
Tetralogy of Fallot
 Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Valve Diseases