News | Medical 3-D Printing | March 13, 2017

Stratasys Opens Enrollment for 3DHEART Clinical Study

Multi-center study will evaluate effects of 3-D-printed pediatric heart models on pre-operative planning

Stratasys, 3DHEART trial, open enrollment, 3-D printed pediatric heart models

March 13, 2017 — Stratasys Ltd. announced last week enrollment is now open for 3DHEART, an investigator-initiated trial. 3DHEART, which stands for 3D Hearts Enabling A Randomized Trial, is a randomized, single-blind clinical trial to study the use of patient-specific 3-D-printed models in pre-operative planning for pediatric heart surgery. Stratasys is providing in-kind support with printing of the models to be used in the trial.

The study is being led by physicians from New York-Presbyterian/Morgan Stanley Children's Hospital, Children’s Hospital of Philadelphia, Children’s National Medical Center and Phoenix Children’s Hospital, with up to 20 additional sites in the U.S. The study will focus on pediatric congenital heart patients requiring complex two-ventricle repair. The primary endpoint being studied is cardiopulmonary bypass time, with secondary endpoints including the prevalence of surgical complications (morbidity), mortality and physician assessment of utility. The study is being managed by OpHeart, a 501(c)3 nonprofit organization whose mission is to improve the odds and outcomes for children born with life-threatening heart defects.

“This study is incredibly important because it will finally quantify what we know from firsthand experience: 3-D-printed, patient-specific models improve surgery, improve outcomes and result in lower treatment costs,” said Yoav Dori, M.D., pediatric cardiologist, Children’s Hospital of Philadelphia. “If we can empirically demonstrate this, it will be a game-changer for treating not only children with congenital heart defects, but patients across the board.”

The study will enroll 400 pediatric patients in total. Stratasys Direct Manufacturing is 3-D printing heart models for 200 patients on Stratasys Connex multi-material, full-color 3-D printers. These models are based on the patients’ magnetic resonance imaging (MRI) or computed tomography (CT) scans, and enable the surgeon to evaluate and “practice” on an accurate replica of the patient’s heart prior to actual surgery. The results of these 200 patients are being compared to the results of 200 patients who are being treated without the aid of 3-D-printed heart models.

For more information: www.stratasys.com

Related Content

Novel Technique May Significantly Reduce Breast Biopsies
News | Breast Biopsy Systems | January 17, 2019
A novel technique that uses mammography to determine the biological tissue composition of a tumor could help reduce...
NewYork-Presbyterian Hospital Partners With Philips for Health IT and Clinical Informatics
News | Enterprise Imaging | January 16, 2019
Philips announced that NewYork-Presbyterian Hospital has chosen to implement the company’s IntelliSpace Enterprise...
Digital Mammography Increases Breast Cancer Detection
News | Mammography | January 16, 2019
The shift from film to digital mammography increased the detection of breast cancer by 14 percent overall in the United...
Artificial Intelligence Used in Clinical Practice to Measure Breast Density
News | Artificial Intelligence | January 15, 2019
An artificial intelligence (AI) algorithm measures breast density at the level of an experienced mammographer,...
Machine Learning Uncovers New Insights Into Human Brain Through fMRI
News | Neuro Imaging | January 11, 2019
An interdisciplinary research team led by scientists from the National University of Singapore (NUS) has successfully...
Mobile App Data Collection Shows Promise for Population Health Surveys
News | Population Health | January 10, 2019
Mobile app data collection can bring access to more potential clinical study participants, reduce clinical study...
Videos | Advanced Visualization | January 09, 2019
Vinodh Kumar, M.D., and Komal Shah, M.D., associate professors of radiology at...
3-D Reconstruction of Ichthyosaurus Skull

A 3-D reconstruction of the ichthyosaurus skull from a computed tomography (CT) scan. Image courtesy of Nigel Larkin, taken at Royal Veterinary College, London.

News | Computed Tomography (CT) | January 09, 2019
A nearly meter-long skull of a giant fossil marine ichthyosaur found in a farmer's field more than 60 years ago has...
Hypertension With Progressive Cerebral Small Vessel Disease Increases Cognitive Impairment Risk
News | Magnetic Resonance Imaging (MRI) | January 08, 2019
Patients with high blood pressure and progression of periventricular white matter hyperintensities showed signs of...