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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02979587
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : September 25, 2019
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Heart Valves )

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 device. The number of subjects implanted will not exceed 45 subjects in the United States and Canada.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

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 and mTPV 25 are 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.

Primary Outcome Measures :
  1. Freedom from procedure- or device-related mortality at 30 days. [ Time Frame: 30 days ]
  2. Percentage of subjects 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. Technical success at exit from catheterization lab/operating room (OR) [ Time Frame: At exit from catheterization lab/operating room (OR) ]
  2. Device Success out to 5 years [ Time Frame: 5 years ]
  3. Procedural Success at 30 days [ Time Frame: 30 days ]
  4. Freedom from TPV Dysfunction out to 5 years [ Time Frame: 5 years ]
  5. Assessment of safety [ Time Frame: 5 years ]
    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: 5 years ]
    As assessed via the SF-36 QOL form.

  7. Characterization of right ventricle remodeling following TPV implant [ Time Frame: 5 years ]
    As assessed via cardiac magnetic resonance imaging

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

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

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 identifier (NCT number): NCT02979587

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Contact: Stephanie Salisbury +16129797251
Contact: Harmony Clinical Study Central Email

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United States, California
Ronald Regan UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Daniel Levi, MD    310-267-7667   
Principal Investigator: Daniel Levi, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Doff McElhinney, MD    650-736-9364   
Principal Investigator: Doff McElhinney, MD         
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Jeremy Asnes, MD    203-785-2022   
Principal Investigator: Jeremy Asnes, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55902
Contact: Allison Cabalka, MD    507-255-5123   
Principal Investigator: Allison Cabalka, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43215
Contact: John P Cheatham, MD, MSCAI    614-722-6124   
Contact: Joanne L Chisolm, MSN, RN    614-355-5736   
Principal Investigator: John P Cheatham, MD, MSCAI         
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Matthew Gillespie, MD    215-590-1790   
Principal Investigator: Matthew Gillespie, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Henri Justino, MD    832-824-1000   
Principal Investigator: Henri Justino, MD         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Robert Gray, MD    801-662-1000   
Principal Investigator: Robert Gray, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Thomas Jones, MD    206-987-2000   
Principal Investigator: Thomas Jones, MD         
Canada, Ontario
The Hospital for Sick Children (SickKids) Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Lee Benson, MD    416-813-6141   
Principal Investigator: Lee Benson, MD         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eric Horlick, MD    416 340 3835   
Principal Investigator: Eric Horlick, MD         
National Cerebral and Cardiovascular Center Not yet recruiting
Suita, Osaka, Japan, 565-8565
Contact: Junjiro Kobayashi, MD    +81 668335012   
Principal Investigator: Junjiro Kobayashi, MD         
Sakakibara Heart Institute Withdrawn
Fuchu, Tokyo, Japan, 183-0003
Sponsors and Collaborators
Medtronic Heart Valves
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Principal Investigator: John P Cheatham, MD Nationwide Children's Hospital

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Responsible Party: Medtronic Heart Valves Identifier: NCT02979587     History of Changes
Other Study ID Numbers: MDT16004CON001
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Heart Diseases
Pulmonary Valve Insufficiency
Tetralogy of Fallot
Cardiovascular Diseases
Congenital Abnormalities
Heart Valve Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities