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

Stereotactic Radiosurgery Effective for Pediatric Arteriovenous Malformation Patients
News | Radiation Therapy | April 19, 2019
Ching-Jen Chen, M.D., of the neurosurgery department at the University of Virginia (UVA) Health System, was the winner...
Video Plus Brochure Helps Patients Make Lung Cancer Scan Decision

Image courtesy of the American Thoracic Society

News | Lung Cancer | April 19, 2019
A short video describing the potential benefits and risks of low-dose computed tomography (CT) screening for lung...
Surgically Guided Brachytherapy Improves Outcomes for Intracranial Neoplasms
News | Brachytherapy Systems | April 18, 2019
Peter Nakaji, M.D., FAANS, general practice neurosurgeon at Barrow Neurological Institute, presented new research on...
Check-Cap Initiates U.S. Pilot Study of C-Scan for Colorectal Cancer Screening
News | Colonoscopy Systems | April 15, 2019
Check-Cap Ltd. has initiated its U.S. pilot study of the C-Scan system for prevention of colorectal cancer through...
Deep Lens Closes Series A Financing for Digital AI Pathology Platform
News | Digital Pathology | April 09, 2019
Digital pathology company Deep Lens Inc. announced the closing of a $14 million Series A financing that will further...
Uterine Fibroid Embolization Safer and as Effective as Surgical Treatment
News | Interventional Radiology | April 05, 2019
Uterine fibroid embolization (UFE) effectively treats uterine fibroids with fewer post-procedure complications compared...
Technological Advancements Expected to Drive Virtual Reality Growth in Healthcare
News | Advanced Visualization | April 04, 2019
Increasing demand for innovative diagnostic techniques, neurological disorders and increasing disease awareness are...
Medivis Unveils AnatomyX Augmented Reality Education Platform
Technology | Advanced Visualization | April 02, 2019
Medical imaging and visualization company Medivis announced the launch of AnatomyX, its augmented reality (AR) platform...
Sponsored Content | Videos | Advanced Visualization | April 01, 2019
GE Healthcare goes beyond core equipment maintenance to help clients solve some of their most important asset and cli
News | Biopsy Systems | March 29, 2019
Dune Medical Devices has just completed the first in-man cases for Smart Biopsy, its percutaneous soft tissue biopsy...