Head-to-head comparison of the Cocoon and Amplatzer PFO Occluders is now underway Mumbai, Maharashtra, India
Sept 02: Congenital Heart Disease (CHD) is one of the most common birth defects, affecting approximately 1% of live births globally and accounting for more than 4.18 million cases in children under five1. Despite advances in medical care, CHD continues to be a leading cause of infant and child mortality, highlighting the need for safe and minimally invasive treatment options. Patent foramen ovale (PFO) is also a common heart defect impacting approximately 25% adults globally2. A PFO is a small opening that can cause blood clots to travel to the brain and potentially lead to stroke These defects are typically treated using Occluders, which are catheter-based devices designed to close abnormal openings in the heart.
The SAFE-PFO trial has enrolled its first patient at Herz- und Diabeteszentrum NRW (HDZ NRW), marking the formal start of recruitment for a randomized head-to-head evaluation of two widely used patent foramen ovale (PFO) closure technologies. The enrolling site is led by Principal Investigator Dr. med. Werner Scholtz. SAFE-PFO will directly compare the Cocoon and Amplatzer PFO closure devices.
The Cocoon Occluder portfolio from SMT comprises catheter-based devices for the minimally invasive closure of Atrial Septal Defects (ASD), patent ductus arteriosus (PDA), ventricular septal defect (VSD) and Patent Foramen Ovale (PFO), and is designed to support the treatment of congenital and acquired heart defects.
The study plans to enroll up to 1,260 patients at approximately 60 centres across Europe. Patients will be randomly assigned to receive either the Cocoon PFO Occluder or a device from the Amplatzer PFO Occluder family. Each patient will be monitored for 12 months, and recruitment across the full study is expected to take about two years.
“This is the first direct head-to-head comparison of the Amplatzer and Cocoon PFO devices, a randomized controlled trial designed to fill an important gap in the clinical evidence for PFO treatment in adults,” stated Prof. Giuseppe Tarantini, Principal Investigator, SAFE-PFO. SAFE-PFO brings together leading centres across Europe to answer an important clinical question.”
Citing the importance of the trial, Dr. Gabor Toth, Co-Principal Investigator of SAFE-PFO, said, “ By directly comparing these two PFO closure devices in a large, randomised study, we hope to provide physicians with clear evidence to help guide treatment decisions for their patients.”
“I welcome the initiation of this important, high-impact trial and look forward to the active participation of several centres across France with experience using both devices for PFO closure,” said Professor Gilles Montalescot, Co-Principal Investigator of SAFE-PFO in France.
Commenting on the trial, Dr. Krishna Sudhir, Chief Medical Officer, SMT, said, “Enrolling the first patient is an important milestone for SAFE-PFO. This study will help cardiologists better understand how the Cocoon PFO Occluder compares with a widely used PFO closure device. Our aim is to generate clinical evidence to support informed treatment decisions and, ultimately, better care for patients with a PFO.”
The Cocoon PFO Occluder features a platinum coating, which effectively mitigates nickel leaching, a common complication associated with traditional nitinol-based Occluders. The study will evaluate its performance against the Amplatzer PFO Occluder family in a randomized controlled setting. No conclusions about comparative safety or effectiveness should be drawn until the study is completed and its results are analysed.