TReatment Of Pulmonary HYpertension 1-US Study

Pulmonary Arterial Hypertension Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02835950
• Other study ID #: CLNS01-001 USA
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: SoniVie Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Intervention

Device:
• Therapeutic Intra-Vascular UltraSound (TIVUS™) System
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	UT Southwestren Medical Center	Dallas	Texas
United States	Columbia University Medical Center/NewYork Presbyterian Hospital	New York	New York
United States	UC San Diego Health	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
SoniVie Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Observational Variables	Changes from baseline of mean pulmonary arterial pressure (mPAP)	12 Months
Other	Observational Variables	Changes from baseline of pulmonary vascular resistance (PVR)	12 Months
Other	Observational Variables	Changes from baseline of 6 minute walking distance (6MWD)	12 Months
Other	Observational Variables	Changes from baseline of quality of life questionaire	12 Months
Other	Observational Variables - Long term surveillance	Clinical change of pulmonary arterial hypertension condition defined by patient survival or cause of mortality	2, 3, 4 and 5 years
Other	Observational Variables - Long term surveillance	Clinical change of pulmonary arterial hypertension condition defined by hospitalization due to pulmonary arterial hypertension	2, 3, 4 and 5 years
Other	Observational Variables - Long term surveillance	Clinical change of pulmonary arterial hypertension condition defined by any intervention or surgical procedures the patient did	2, 3, 4 and 5 years
Other	Observational Variables - Long term surveillance	Clinical change of pulmonary arterial hypertension condition defined by worsening of WHO functional class	2, 3, 4 and 5 years
Other	Observational Variables - Long term surveillance	Clinical change of pulmonary arterial hypertension condition defined by escalation of drug therapy	2, 3, 4 and 5 years
Other	Observational Variables	Echocardiography parameters	12 month
Primary	Amount of all procedural related adverse event as assessed by the CEC	Procedural related Adverse Events	1 month
Primary	Amount of treatment related adverse event as assessed by the CEC	All treatment related adverse events	12 month
Primary	Number of patient with PAH worsening and all cause death events	PAH related adverse events and all cause death	12 month
Secondary	Clinical effectiveness	Changes from baseline of mean pulmonary arterial pressure (mPAP)	6 months
Secondary	Clinical effectiveness	Changes from baseline of pulmonary vascular resistance (PVR)	6 months
Secondary	Clinical effectiveness	Changes from baseline of 6 minute walking distance (6MWD)	6 months
Secondary	Clinical effectiveness	Changes from baseline of quality of life questionaire	6 months
Secondary	Clinical effectiveness	NT-pro-BNP levels	1, 6 and 12 months
Secondary	Clinical efffectivness	Change from baseline in Right Ventricular (RV) function as assesed by MRI	6 months
Secondary	Clinical efffectivness	Change from baseline in Right Ventricular (RV) function as assesed by Echocardiography	6 months