TReatment Of Pulmonary HYpertension 1 Study

Pulmonary Arterial Hypertension Clinical Trial

— TROPHY  

Official title:

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02516722
• Other study ID #: CLNS01-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 2021

Study information

• Verified date: March 2021
• 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 5 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: June 2021
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with known pulmonary arterial hypertension (PAH), which has been diagnosed as idiopathic PAH, connective tissue disease PAH, anorexigen induced or familial 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 should be on 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:

• Patient who are treated with parenteral prostanoids

• Pregnant women or women planning a pregnancy within 12 months of study enrolment

• Patient with significant co-morbid conditions 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

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
Belgium	Hôpital Erasme	Bruxelles
Israel	Kaplan Hospital	Rehovot
United Kingdom	Hammersmith Hospital, Imperial College Healthcare NHS Trust	London
United Kingdom	Royal Hallamshire Hospital,	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
SoniVie Inc.

Countries where clinical trial is conducted

Belgium,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Observational Variables	Changes from baseline of Nt-pro-BNP	12 Months
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 a. Survival or the cause of mortality; b. Hospitalization due to pulmonary arterial hypertension; c. Intervention or surgical procedures; d. Worsening of WHO functional class and/or e. Escalation of drug therapy	3 years
Primary	Safety evaluation of the PDN procedure (Procedural related Adverse Events)	Procedural related Adverse Events	1 month
Primary	Safety evaluation of the PDN procedure (PAH related adverse events and all cause death)	PAH related adverse events and all cause death	12 month
Secondary	Clinical effectiveness	Changes from baseline of mean pulmonary arterial pressure (mPAP)	4 months
Secondary	Clinical effectiveness	Changes from baseline of pulmonary vascular resistance (PVR)	4 months
Secondary	Clinical effectiveness	Changes from baseline of 6 minute walking distance (6MWD)	4 months
Secondary	Clinical effectiveness	Changes from baseline of quality of life questionaire	4 months