Western Ireland’s University Hospital Galway Leading Advanced Heart Failure Monitoring Clinical Trial

Cardiology-focused Investigators from University Hospital Galway complete a first-in-man clinical trial for a sensor that may help patients with heart failure stay out of the hospital. The investigational product, known as the Cordella Sensor from U.S.-based company called Endotronix, detects changes in the health of patients with heart failure while securely transmitting information to the cardiovascular team. With this data in real time, the cardiovascular team can not only receive relevant updates but also can intervene with the goal of preventing heart failure flare-up resulting in emergency hospitalization.

Timely Intervention for Heart Failure

With the advent of the COVID-19 pandemic and associated movement restrictions and lockdowns, this investigational technology may be of particular importance when patient’s movement is restricted to prevent contact with SARS-CoV-2, the virus behind the COVID-19 pandemic, as reported by the Saolta University Health Care Group.

Track Record thus Far

The Western Ireland-based hospital has treated seven advanced heart failure patients to date: implanting the Cordella Sensor in their right pulmonary artery to monitor their heart pressure during the past 18 months.

Enabling Remote Cardiovascular Care Monitoring & Care Coordination

The Cordella Sensor uses a secure cloud-based system to enable the clinical team located in the hospital to read the physiological data captured by the sensor. In this way, the patient can be safe at home while the hospital team can not only monitor and identify any material changes in the patients’ condition but also modify their medication and make other timely care decisions.

The Study

Led by Dr. Faisal Sharif, Consultant Cardiologist at University Hospital Galway and Director of Cardiovascular Research and Innovation Centre at NUIG, is the lead for the clinical trial. The prospective, multi-center, open-label, single-arm CE-Mark trial has been organized to assess device safety and efficacy of the Cordella PA Sensor System. Sponsored by Endotronix, Inc. research sites in addition to Galway University Hospital include Mater Misericordiae University Hospital (Ireland),  as well as centers in Germany and Belgium.

Investigator Comments

Dr. Sharif mentioned that “Patients with advanced heart failure usually have 3 or 4 hospital admissions per year with each stay lasting between 2 and 3 weeks in order to get their flare-up under control.” But Dr. Sharif emphasized that this technology can impact this current situation if “changes are detected in time, myself or my colleague Dr. John Barton can make changes to the patients’ medication which will prevent the flare-up and the and the subsequent hospital admission.”

Dr. Pat Nash, Consultant Cardiologist at UH reports that the COVID-19 pandemic has forced health systems and providers to find “new and innovative ways” to help cardiovascular patients. He continued that this trial’s success should be evaluated by how well the patient’s quality of life is improved including the reduction in hospitalizations.

Investigational Product

The product was developed by a U.S.-based venture called Endotronix. For more information on the Cordella product, see the link. 

The Research Site

University Hospital Galway is part of the Saolta University Health Care Group, which includes several hospitals, such as Letterkenny University Hospital, Mayo University Hospital, Merlin Park University Hospital, Portiuncula University Hospital, Roscommon University Hospital, and Sliqo University Hospital. For a full brief on the health system’s strategy, see the link. 

The Sponsor

Endotronix was born in 2007 when a cardiothoracic surgeon, Anthony Nunez, MD, met a mechanical engineer named Harry Roland, PhD. After sharing stories of how family members suffered from heart failure (HF), the two launched a new startup at the time as they both felt  uniquely qualified to invent a more effective solution to improve the quality of life for HF sufferers, their loved ones, and caregivers. They assembled a team to develop technology and together they built the company over the past decade. The company has raised $124 million in venture capital rounds, according to Crunchbase.

Lead Research/Investigator

Dr. Faisal Sharif, Consultant Cardiologist at Galway University Hospital, and Director of Cardiovascular Research and Innovation Centre at NUIG