NCT04570228Not yet recruitingNot Applicable
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- SoniVie Inc.
- Enrollment
- 205
- Primary Endpoint
- The rate of procedure and treatment related SAEs reported
Study Overview
Brief Summary
Theis is a prospective, multicenter, blinded, randomized sham controlled pivotal clinical trial with a crossover at 6M, to assess the safety and effectiveness of pulmonary artery denervation with the TIVUS™ System in subjects with PAH. The study will assess improved and/or maintained exercise tolerance in patients with PAH through the analysis of exercise tolerance, hemodynamic changes, clinical worsening and the quality of life who got treated by the TIVUS system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure.
- •Male or female ≥ 18 years of age at the time of screening
- •Subject with known pulmonary arterial hypertension (PAH), which has been diagnosed as idiopathic PAH, connective tissue disease PAH, anorexigen induced, familial PAH or corrected congenital heart defects more than 1 year prior to enrollment, confirmed by right heart catheterization performed prior to screening and showing all of the following:
- •Mean pulmonary artery pressure (mPAP) ≥25 mmHg at rest
- •Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg
- •Pulmonary vascular resistance (PVR) at rest >3 Wood units (240 dyne*s/cm^5)
- •Subject is on maximally tolerated medical therapy for PAH, as determined by his PAH physician
- •Subject is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
- •Subject is able to tolerate IV contrast used for the angiograms during treatment
- •Subject is WHO functional class II or III
Exclusion Criteria
- •Subject is treated with parenteral prostanoids and has not been on a stable dose for at least 3 months
- •Subjects with portal-pulmonary hypertension, Group 2, 3 and 4 PH
- •Pregnant women or women planning a pregnancy within 12 months of study enrolment
- •Subject with significant co-morbid conditions which, at the discretion of the PI, are deemed to prohibit study entry
- •Subject with life expectancy of less than a year
- •Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
- •Subject with pulmonary artery anatomy that precludes treatment with the TIVUS System
- •Subject who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
- •Subject experiencing a current episode of acute decompensated heart failure
- •Subject who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrollment.
- •Subject who has implantable Cardiomems device, or other implanted device that might be contraindicated for therapeutic ultrasound energy.
Arms & Interventions
Treatment group
Active Comparator
Pulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization and pulmonary artery angiography.
Intervention: Pulmonary artery denervation (Device)
Sham control group
Sham Comparator
A sham treatment of pulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization pulmonary artery angiography. The sham procedure will be identical to the denervation procedure, with the only exception that the procedure will use a sham setting on the control console.
Intervention: Sham procedure (Device)
Outcomes
Primary Outcomes
The rate of procedure and treatment related SAEs reported
Time Frame: 12 months
6 minute walking distance (6MWD)
Time Frame: 6 months
Statistical difference in 6MWD between the treated group and the sham control group
Secondary Outcomes
- Difference between the treated group and the sham control group in patients' clinical pulmonary arterial hypertension condition defined by worsening of World Health Organization (WHO) functional class(6 months)
- Difference between the treated group and the sham control group in resting pulmonary vascular resistance (PVR)(6 months)
- Difference between time to clinical worsening event between the treated group and the sham control group(6 months)
- Difference between the treated group and the sham control group in resting mean right atrial pressure (mRAP)(6 months)
- Difference between the treated group and the sham control group in resting cardiac index (CI)(6 months)
- Statistical difference between the treated group and the sham control group in exercise tolerance as measured using the change in activity parameters using the Actigraph Centrepoint watch(6 months)
- Difference between the treated group and the sham control group in resting mean pulmonary artery pressure (mPAP)(6 months)
- Percent of patients who improve or maintain their exercise tolerance (as measured by 6MWD and actigraphy)(6 months)
- Difference between the treated group and the sham control group in Quality of Life (QOL) score using the SF36 questionnaire(6 months)
- Difference between the treated group and the sham control group of NT-pro-BNP levels(6 months)
- Difference between the number of clinical worsening events between the treated group and the sham control group(6 months)
Investigators
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