TReatment of Pulmonary Hypertension Group II Study (TROPHY-II)

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Hypertension Due to Left Heart Disease

The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life.

This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR>3 wood units.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Hypertension (PH) Due to Left Heart Disease
• Intervention / Treatment: Device: Pulmonary Denervation

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • UC San Diego Medical Center
    • San Francisco, California, United States, 94158
      • University of California, San Francisco Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2696
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
• Male or female, ≥ 18 years of age at the time of screening
• Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
• Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
• Patient with a current diagnosis of NYHA functional class II/III
• Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150μmol/l

Exclusion Criteria:

• Pregnant women or women planning a pregnancy within 12 months of study enrolment
• Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
• Patient 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)
• Patient with pulmonary artery anatomy that precludes treatment
• Patient with moderate to severe pulmonary artery stenosis
• Patient with any pulmonary artery aneurysm
• Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
• Patient experiencing a current episode of acute decompensated heart failure
• Patient who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrolment. Patient who has implantable Cardiomems device, neurostimulators or drug infusion devices, regardless of implant date.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural related Adverse Events (complications) at up to 30 days post procedure	Procedural related Adverse Events (complications) at up to 30 days post procedure including pulmonary artery perforation/dissection, acute thrombus formation in the pulmonary artery, pulmonary artery aneurysm, vascular stenosis, hemoptysis, all cause PH related as well as procedural related death.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cardiopulmonary exercise test	Changes in cardiopulmonary exercise test (CPET) results (Peak VO2, VE/VCO2 slope, VO2 at anaerobic threshold, peak workload) from baseline	4 month
Change in resting mean right atrial pressure	Change in resting mean atrial pressure (mRAP) from baseline	4 month
Changes in 6MWD from baseline	Changes in 6MWD from baseline	4 month
Changes in Echocardiography parameters	Changes in Echocardiography parameters including Right Ventricular function from baseline	4 month
Change in NT-BNP levels	Change in NT-BNP levels from baseline	4 month
Procedure related and PH worsening adverse events	Procedure related and PH worsening adverse events and all cause death up to 12 months will be recorded, and serious adverse events will be reported in accordance with regulatory requirements.	12 month
Change in exercise mean right atrial pressure	Change in exercise mean right atrial pressure (mRAP) from baseline	4 month
Change in exercise mean pulmonary artery pressure	Change in exercise mean pulmonary artery pressure (mPAP) from baseline	4 month
Change in exercise pulmonary vascular resistance	Change in exercise pulmonary vascular resistance (PVR) from baseline	4 month
Change in exercise cardiac index	Change in exercise cardiac index (CI) from baseline	4 month
Change in resting mean pulmonary artery pressure	Change in resting mean pulmonary artery pressure (mPAP) from baseline	4 month
Change in resting pulmonary vascular resistance	Change in resting pulmonary vascular resistance (PVR) from baseline	4 month
Change in resting cardiac index	Change in resting cardiac index (CI) from baseline	4 month

Collaborators and Investigators

• Sponsor: SoniVie Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: CLNS02-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes