Pulmonary Hypertension (PH) Due to Left Heart Disease Clinical Trial
— TROPHY-IIOfficial title:
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Hypertension Due to Left Heart Disease
| Verified date | August 2023 |
| Source | SoniVie Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 15 |
| Est. completion date | July 2027 |
| Est. primary completion date | December 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | UC San Diego Medical Center | San Diego | California |
| United States | University of California, San Francisco Medical Center | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| SoniVie Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Change in resting mean right atrial pressure | Change in resting mean atrial pressure (mRAP) from baseline | 4 month | |
| Secondary | Changes in 6MWD from baseline | Changes in 6MWD from baseline | 4 month | |
| Secondary | Changes in Echocardiography parameters | Changes in Echocardiography parameters including Right Ventricular function from baseline | 4 month | |
| Secondary | Change in NT-BNP levels | Change in NT-BNP levels from baseline | 4 month | |
| Secondary | 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 | |
| Secondary | Change in exercise mean right atrial pressure | Change in exercise mean right atrial pressure (mRAP) from baseline | 4 month | |
| Secondary | Change in exercise mean pulmonary artery pressure | Change in exercise mean pulmonary artery pressure (mPAP) from baseline | 4 month | |
| Secondary | Change in exercise pulmonary vascular resistance | Change in exercise pulmonary vascular resistance (PVR) from baseline | 4 month | |
| Secondary | Change in exercise cardiac index | Change in exercise cardiac index (CI) from baseline | 4 month | |
| Secondary | Change in resting mean pulmonary artery pressure | Change in resting mean pulmonary artery pressure (mPAP) from baseline | 4 month | |
| Secondary | Change in resting pulmonary vascular resistance | Change in resting pulmonary vascular resistance (PVR) from baseline | 4 month | |
| Secondary | Change in resting cardiac index | Change in resting cardiac index (CI) from baseline | 4 month |