By: IPP Bureau
Last updated : September 03, 2026 7:58 am
The trial will evaluate the two widely used PFO closure technologies in adults, addressing the need for comparative clinical evidence in minimally invasive treatment of the condition
The SAFE-PFO trial by Sahajanand Medical Technologies (SMT) has enrolled its first patient at Herz- und Diabeteszentrum NRW (HDZ NRW), marking the start of a randomised head-to-head study comparing the Cocoon and Amplatzer patent foramen ovale (PFO) closure devices
The enrolling site is led by Principal Investigator Dr. med. Werner Scholtz. The trial will evaluate the two widely used PFO closure technologies in adults, addressing the need for comparative clinical evidence in minimally invasive treatment of the condition.
Congenital heart disease (CHD) affects approximately 1% of live births globally and accounts for more than 4.18 million cases among children under five.
PFO, meanwhile, is estimated to affect around 25% of adults globally. The condition involves a small opening between the heart’s upper chambers that can allow blood clots to travel to the brain and potentially cause stroke.
These structural heart defects can be treated using occluders, catheter-based devices designed to close abnormal openings in the heart.
The SAFE-PFO trial plans to enrol up to 1,260 patients across approximately 60 centres in Europe. Participants will be randomly assigned to receive either the Cocoon PFO Occluder or a device from the Amplatzer PFO Occluder family and will be followed for 12 months. Recruitment across the study is expected to take approximately 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.”
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.
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 study is designed to generate comparative clinical evidence; no conclusions regarding the relative safety or effectiveness of the two devices should be drawn until the trial is completed and its results analysed.