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Medical Technology

A Cardiovascular Clinical Trial Network was founded in 2017 to deliver Cardiovascular clinical trials with a particular focus on device-based trials. The impetus for enabling device-based Cardiovascular trials was impelled by the vibrant medical technologies sector in Galway and the strategic remit of NUI Galway, to prioritise research linked to Medical Technologies, Translational Clinical Research and Clinical Trials.

Over the last 3 years, MedTech trials research team has developed a portfolio of industry-sponsored trials, collaborating with Cardiology colleagues within Galway University Hospital (GUH), and connecting regionally to Cardiology colleagues across the Saolta HealthCare Group (an area which serves approximately 800,000 patients in the West and North-west of Ireland) for patient-referral, recruitment and follow-up supports.

Our core outcomes are:

  1. To deliver very high quality cardiovascular clinical research
  2. To improve quality of life and monitor quality of care through novel interventions
  3. To enhance patients experience through their involvement in clinical trials
  4. To respect patients autonomy
  5. To provide patient education to empower patients about their health.

To date, the HRB CRFG MedTech research team has participated in 33 medical device clinical trials. These trials ranged from FIH to phase 3 multicenter randomized control trials. The MedTech research team in embedded within the HRB CRFG structure and provides high quality clinical trials by adhering to all regulatory and GCP standards.

The MedTech research team employs 5 full-time research staff including senior research nurses, clinical research associates and a data manager. MedTech research team has delivered very high level of patient rectruitment, patient retension, and patient experience in multiple complex multi center global and European clinical trials.

This research is led by Professor Faisal Sherif.

Examples of ongoing and recent trials:

ONYX ONE (Coronary Artery Disease trial)

This multi-center Global 90 sites RCT was for patients who were high bleeding risk from prolonged dual anti platelets treatment after undergoing coronary artery stenting. The trial compared Medtronic Resolute Onyx stent vs Biofreedom stent. University of Galway was the third highest enrolling site for this trial that showed that Resolute Onyx was similar in effectiveness to Biofreedom stent and dual anti platelet treatment may be reduced to 1-month post stenting in patients who are high bleeding risk without the risk of excessive stent thrombosis.

SPYRAL OFF MED RCT (Arterial Hypertension Trial)

This is Global Clinical Study of Renal Denervation With the Symplicity SpyralTM Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED). The trial was the first ever SHAM controlled trial in Ireland. This was executed very professionally and NUI Galway were the 3rd highest recruiter in Europe for this trial. The device has shown to effective and will lead to less medications or less medication doses for patients with arterial hypertension.

SIRONA FIM and 2 RCTs (Advanced Heart Failure Trials) 

SIRONA 1 was the “FIM” safety and feasibility trial for patients with advanced heart failure for remote monitoring of their pulmonary artery pressures. The protocol for device placement was developed by the investigators at University of Galway. We placed 7 successful cordella sensors in the right pulmonary arteries of these patients. The device safety and feasibility was conformed with no patients side effects. This let to our participation in the SIRONA 2 CE marked device. University of Galway has the highest number of device implanted among 8 European sites. The trial has really emphasized the importance of patient education and patient engagement. The patients are now part of this important clinical trial really highlighting the impact of patient empowerment. The trial has improved patients quality of life with no hospital admissions with acute heart failure post sensor implantation.

University of Galway and Galway University Hospital (GUH) are pursuing the building of a National Clinical Trial Centre for Medical Devices. The proposed facility will incorporate a Hybrid Cardiac Catheterisation Laboratory (HCCL) and CT scanner suites which will allow early testing of novel medical devices. This will address a significant translational gap in this area to ensure Ireland becomes a global hub for medical device technology. The project has a transformative potential to bring academia, hospital and industry together with other relevant stakeholders to improve patient care with societal and economics impact. It will also further embed medical device companies, which currently employ 32,000 people in Ireland and will contribute to an ecosystem which will facilitate SME formation.