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JACC Cardiovasc Interv. 2017 Sep 11;10(17):1763-1773. doi: 10.1016/j.jcin.2017.05.034.

Harmony Feasibility Trial: Acute and Short-Term Outcomes With a Self-Expanding Transcatheter Pulmonary Valve.

Author information

Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts. Electronic address:
Division of Cardiology, Labatt Family Heart Center, Hospital for Sick Children, Toronto, Ontario, Canada.
Department of Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Department of Cardiology, Nationwide Children's Hospital, Columbus, Ohio.
Peter Munk Cardiac Centre, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada; Joint Department of Medical Imaging, Toronto General Hospital, Toronto, Ontario, Canada.
Peter Munk Cardiac Centre, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.
Coronary and Structural Heart Clinical Department, Medtronic, Santa Rosa, California.
Coronary and Structural Heart Research and Innovation Department, Medtronic, Mounds View, Minnesota.
Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts.



This study sought to obtain in vivo data to confirm assumptions on device loading conditions and assess procedural feasibility, safety, and valve performance.


The Harmony transcatheter pulmonary valve (Medtronic, Minneapolis, Minnesota) was designed for patients with severe pulmonary regurgitation who require pulmonary valve replacement.


Three sites participated in this first Food and Drug Administration-approved early feasibility study using an innovative device design to accommodate the complex anatomy of the right ventricular outflow tract. Potentially eligible patients underwent review by a screening committee to determine implant eligibility. Six-month outcomes are reported.


Between May 2013 and May 2015, 66 subjects were enrolled, and 21 were approved for implant and underwent catheterization; 20 were implanted. Catheterized patients had a median age of 25 years, were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%), and had trivial or mild stenosis. The device was delivered in the desired location in 19 of 20 (95%) patients. Proximal migration occurred in 1 patient during delivery system removal. Two devices were surgically explanted. Premature ventricular contractions related to the procedure were reported in 3 patients; 2 were resolved without treatment. One patient had ventricular arrhythmias that required treatment and later were resolved. At 1 month, echocardiography revealed none or trivial pulmonary regurgitation in all and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range 6 to 31 mm Hg).


In this feasibility study of the Harmony transcatheter pulmonary valve device, there was high procedural success and safety, and favorable acute device performance.


Harmony TPV; RVOT conduit; tetralogy of Fallot; transcatheter pulmonary valve

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