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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.
ClinicalTrials.gov Identifier: NCT02979587
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Congenital Heart Disease Tetrology of Fallot RVOT Anomaly Pulmonary Regurgitation Device: Harmony TPV System

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : December 2018
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Harmony TPV System
Intervention Device: Harmony Transcatheter Pulmonary Valve and Delivery System
Device: Harmony TPV System
The Harmony™ TPV is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame. The Harmony Delivery System is a 25 Fr coil loading catheter delivery system.


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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

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


Contacts
Contact: Kristin J Boulware 763-514-9809 kristin.j.boulware@medtronic.com

Locations
United States, California
Ronald Regan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Daniel Levi, MD    310-267-7667    dlevi@ucla.edu   
Principal Investigator: Daniel Levi, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Doff McElhinney, MD    650-736-9364    doff@stanford.edu   
Principal Investigator: Doff McElhinney, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Jeremy Asnes, MD    203-785-2022    jeremy.asnes@yale.edu   
Principal Investigator: Jeremy Asnes, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Allison Cabalka, MD    507-255-5123    Cabalka.Allison@mayo.edu   
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    John.Cheatham@nationwidechildrens.org   
Contact: Joanne L Chisolm, MSN, RN    614-355-5736    Joanne.Chisolm@nationwidechildrens.org   
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    GILLESPIE@email.chop.edu   
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    hxjustin@texaschildrens.org   
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    Robert.Gray@utah.edu   
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    thomas.jones@seattlechildrens.org   
Principal Investigator: Thomas Jones, MD         
Canada, Ontario
Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eric Horlick, MD    416 340 3835    Eric.Horlick@uhn.ca   
Principal Investigator: Eric Horlick, MD         
Sponsors and Collaborators
Medtronic Heart Valves
Investigators
Principal Investigator: John P Cheatham, MD Nationwide Children's Hospital
More Information

Responsible Party: Medtronic Heart Valves
ClinicalTrials.gov Identifier: NCT02979587     History of Changes
Other Study ID Numbers: MDT16004CON001
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

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:
Heart Diseases
Pulmonary Valve Insufficiency
Respiratory Insufficiency
Tetralogy of Fallot
Cardiovascular Diseases
Heart Valve Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities