Back to resultsTReatment Of Pulmonary HYpertension 1-US Study (TROPHY 1-US)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Intra-Vascular UltraSound (TIVUS™) System
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
- Patient with known pulmonary arterial hypertension (PAH), diagnosed as idiopathic PAH, connective tissue disease PAH, Anorexogen induced or Heritable PAH
- PAH diagnosis confirmed by hemodynamic evaluation 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; Not meeting the criteria for a positive vasodilator response (fall in mPAP ≥ 10 mmHg to ≤ 40 mmHg).
- Patient with a current diagnosis of WHO functional class III
- Patient taking two pulmonary arterial hypertension specific medications other than parenteral prostanoids
- Patient 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)
- Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150µmol/l
Exclusion Criteria:
- Patients who are treated with parenteral prostanoids
- 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 who has implantable cardiac pacemakers, ICDs, neurostimulators, or drug infusion devices
- Patients who are unable to undergo an MRI scan
Sites / Locations
- UC San Diego Health
- University of Michigan
- Columbia University Medical Center/NewYork Presbyterian Hospital
- UT Southwestren Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary Denervation
Arm Description
Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary arterial hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up.
Outcomes
Primary Outcome Measures
Amount of all procedural related adverse event as assessed by the CEC
Procedural related Adverse Events
Amount of treatment related adverse event as assessed by the CEC
All treatment related adverse events
Number of patient with PAH worsening and all cause death events
PAH related adverse events and all cause death
Secondary Outcome Measures
Clinical effectiveness
Changes from baseline of mean pulmonary arterial pressure (mPAP)
Clinical effectiveness
Changes from baseline of pulmonary vascular resistance (PVR)
Clinical effectiveness
Changes from baseline of 6 minute walking distance (6MWD)
Clinical effectiveness
Changes from baseline of quality of life questionaire
Clinical effectiveness
NT-pro-BNP levels
Clinical efffectivness
Change from baseline in Right Ventricular (RV) function as assesed by MRI
Clinical efffectivness
Change from baseline in Right Ventricular (RV) function as assesed by Echocardiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02835950
Brief Title
TReatment Of Pulmonary HYpertension 1-US Study
Acronym
TROPHY 1-US
Official Title
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
April 20, 2019 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SoniVie Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to assess the safety, performance and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation through subjective and objective change in clinical parameters and haemodynamic evaluation. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific medications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Denervation
Arm Type
Experimental
Arm Description
Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary arterial hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up.
Intervention Type
Device
Intervention Name(s)
Therapeutic Intra-Vascular UltraSound (TIVUS™) System
Other Intervention Name(s)
TIVUS™
Intervention Description
The TIVUS™ System generates high intensity, non-focused ultrasonic energy that is delivered through the wall of the pulmonary artery to achieve local nerve deactivation.
Denervation in the pulmonary arteries (PDN) would be performed during right heart catheterization. The PDN procedure would be attempted in the main, right and left pulmonary arteries, close to the main bifurcation.
Primary Outcome Measure Information:
Title
Amount of all procedural related adverse event as assessed by the CEC
Description
Procedural related Adverse Events
Time Frame
1 month
Title
Amount of treatment related adverse event as assessed by the CEC
Description
All treatment related adverse events
Time Frame
12 month
Title
Number of patient with PAH worsening and all cause death events
Description
PAH related adverse events and all cause death
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Clinical effectiveness
Description
Changes from baseline of mean pulmonary arterial pressure (mPAP)
Time Frame
6 months
Title
Clinical effectiveness
Description
Changes from baseline of pulmonary vascular resistance (PVR)
Time Frame
6 months
Title
Clinical effectiveness
Description
Changes from baseline of 6 minute walking distance (6MWD)
Time Frame
6 months
Title
Clinical effectiveness
Description
Changes from baseline of quality of life questionaire
Time Frame
6 months
Title
Clinical effectiveness
Description
NT-pro-BNP levels
Time Frame
1, 6 and 12 months
Title
Clinical efffectivness
Description
Change from baseline in Right Ventricular (RV) function as assesed by MRI
Time Frame
6 months
Title
Clinical efffectivness
Description
Change from baseline in Right Ventricular (RV) function as assesed by Echocardiography
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Observational Variables
Description
Changes from baseline of mean pulmonary arterial pressure (mPAP)
Time Frame
12 Months
Title
Observational Variables
Description
Changes from baseline of pulmonary vascular resistance (PVR)
Time Frame
12 Months
Title
Observational Variables
Description
Changes from baseline of 6 minute walking distance (6MWD)
Time Frame
12 Months
Title
Observational Variables
Description
Changes from baseline of quality of life questionaire
Time Frame
12 Months
Title
Observational Variables - Long term surveillance
Description
Clinical change of pulmonary arterial hypertension condition defined by patient survival or cause of mortality
Time Frame
2, 3, 4 and 5 years
Title
Observational Variables - Long term surveillance
Description
Clinical change of pulmonary arterial hypertension condition defined by hospitalization due to pulmonary arterial hypertension
Time Frame
2, 3, 4 and 5 years
Title
Observational Variables - Long term surveillance
Description
Clinical change of pulmonary arterial hypertension condition defined by any intervention or surgical procedures the patient did
Time Frame
2, 3, 4 and 5 years
Title
Observational Variables - Long term surveillance
Description
Clinical change of pulmonary arterial hypertension condition defined by worsening of WHO functional class
Time Frame
2, 3, 4 and 5 years
Title
Observational Variables - Long term surveillance
Description
Clinical change of pulmonary arterial hypertension condition defined by escalation of drug therapy
Time Frame
2, 3, 4 and 5 years
Title
Observational Variables
Description
Echocardiography parameters
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with known pulmonary arterial hypertension (PAH), diagnosed as idiopathic PAH, connective tissue disease PAH, Anorexogen induced or Heritable PAH
PAH diagnosis confirmed by hemodynamic evaluation 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; Not meeting the criteria for a positive vasodilator response (fall in mPAP ≥ 10 mmHg to ≤ 40 mmHg).
Patient with a current diagnosis of WHO functional class III
Patient taking two pulmonary arterial hypertension specific medications other than parenteral prostanoids
Patient 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)
Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150µmol/l
Exclusion Criteria:
Patients who are treated with parenteral prostanoids
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 who has implantable cardiac pacemakers, ICDs, neurostimulators, or drug infusion devices
Patients who are unable to undergo an MRI scan
Facility Information:
Facility Name
UC San Diego Health
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Columbia University Medical Center/NewYork Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UT Southwestren Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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TReatment Of Pulmonary HYpertension 1-US Study
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