TReatment Of Pulmonary HYpertension (TROPHY) 1 study, UK version 1
Research type
Research Study
Full title
Clinical evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for pulmonary artery denervation in patients with pulmonary hypertension
IRAS ID
185434
Contact name
Assaf Bernstein
Contact email
Sponsor organisation
SoniVie Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Summary of Research
This is a prospective, multicenter, non-randomized, open-label clinical investigation to assess the safety, performance and initial clinical effectiveness of the TIVUS™ system in patients with pulmonary hypertension.
Study participants, Male or female, at least 18 years of age, will undergo pulmonary artery denervation (deactivating of some of the nerves affecting the blood flow to the lungs). During right heart catheterisation, ultrasound (high frequency sound) energy will be used to damage some of the nerves, which may lead to reduced blood pressure in the lung, improved heart function, exercise capacity, activity levels and wellbeing for the patient.
The screening period will last for up to 45 days and if patients are eligible, the right heart catheterisation and denervation procedure will be performed (the index procedure). Patients will attend the hospital/clinic up to 12 months post index procedure, at 2 weeks (optional), 1, 4, 8 and 12 months. The treatment period will therefore last for 12 months.
After the study visits are complete (12 months after the initial right heart catheterisation), long-term follow up health data will be collected from the patient's medical records for another 2 years.
This study is designed to investigate the safety and feasibility of pulmonary artery denervation: measured by the reporting of adverse events and changes in haemodynamic (blood flow) measurements recorded during right heart catheterisation during the index procedure and also at the 4 and 12 month study visits.
Study participants will undertake various study tests including cardiac MRI (or CT scan), ECGs, blood pressure, heart rate and breathing rate measurements, 6 minute walk test, measurement of biomarkers and laboratory assessments, activity monitoring and completion of quality of life questionnaires.
Summary of Results
Pulmonary Arterial Hypertension occurs when the blood pressure in the pulmonary arteries (the vessels that bring blood to the lungs) is increased due to narrowing of the small arteries of the lungs. In this study, the TIVUS™ System was used to carry out a new procedure called pulmonary artery denervation. By deactivating some of the nerves around the pulmonary arteries, pulmonary artery denervation was hoped to lead to reduced blood pressure in the lungs, improved heart function, exercise capacity, activity levels and wellbeing. The pulmonary artery denervation procedure used ultrasonic (high frequency sound) energy during a right heart catheterization procedure. The main aim of this study was to collect information about the safety of the denervation treatment of the TIVUS™ System in adult patients with pulmonary hypertension.
In total, 14 participants were enrolled in the CLNS01-001 study for an initial one-year hospital visit follow-up which was then followed by a long-term surveillance up to 36 months after the pulmonary artery denervation procedure date.
The Trophy-1 Study demonstrated initial safety of the TIVUS™ System when used for the treatment of pulmonary arterial hypertensive patients. The treatment was well tolerated by most of the patients, with pain well managed when present during the treatment and during the study no device-related or procedure-related serious adverse events were reported which demonstrated the safety of the procedure. The pre-specified effectiveness endpoints noted in the Patient Information Sheet were for haemodynamic evaluation, quality of life score and the 6 Minute Walk Distance.
At the 4-month follow-up a statistically significant reduction was identified in the haemodynamic measurements for the mean pulmonary artery pressure, pulmonary vascular resistance and the right atrial pressure. Improvement was also identified in the patient cardiac output, activity levels using the wrist actigraphy data collection device, the 6-minute walking distance completed and the quality of life questionnaire score. In addition, the procedure was well tolerated by the patients, the catheter was easy to use, and the pulmonary artery denervation procedure was around 30 minutes in duration
Long-term follow-up of the participants indicated a potential benefit of the TIVUS™ System treatment up to 18 months following treatment. These very first results are promising and support future clinical studies to the confirm the good safety profile previously seen and to see if a repeat treatment from 18-24 months could be beneficial to patients.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0327
Date of REC Opinion
16 Oct 2015
REC opinion
Further Information Favourable Opinion