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TReatment Of Pulmonary HYpertension 1-US Study (TROPHY 1-US)

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ClinicalTrials.gov Identifier: NCT02835950
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
SoniVie Ltd.

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Device: Therapeutic Intra-Vascular UltraSound (TIVUS™) System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
Experimental: Pulmonary Denervation
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.
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.

Other Name: TIVUS™




Primary Outcome Measures :
  1. Amount of all procedural related adverse event as assessed by the CEC [ Time Frame: 1 month ]
    Procedural related Adverse Events

  2. Amount of treatment related adverse event as assessed by the CEC [ Time Frame: 12 month ]
    All treatment related adverse events

  3. Number of patient with PAH worsening and all cause death events [ Time Frame: 12 month ]
    PAH related adverse events and all cause death


Secondary Outcome Measures :
  1. Clinical effectiveness [ Time Frame: 6 months ]
    Changes from baseline of mean pulmonary arterial pressure (mPAP)

  2. Clinical effectiveness [ Time Frame: 6 months ]
    Changes from baseline of pulmonary vascular resistance (PVR)

  3. Clinical effectiveness [ Time Frame: 6 months ]
    Changes from baseline of 6 minute walking distance (6MWD)

  4. Clinical effectiveness [ Time Frame: 6 months ]
    Changes from baseline of quality of life questionaire

  5. Clinical effectiveness [ Time Frame: 1, 6 and 12 months ]
    NT-pro-BNP levels

  6. Clinical efffectivness [ Time Frame: 6 months ]
    Change from baseline in Right Ventricular (RV) function as assesed by MRI

  7. Clinical efffectivness [ Time Frame: 6 months ]
    Change from baseline in Right Ventricular (RV) function as assesed by Echocardiography


Other Outcome Measures:
  1. Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of mean pulmonary arterial pressure (mPAP)

  2. Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of pulmonary vascular resistance (PVR)

  3. Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of 6 minute walking distance (6MWD)

  4. Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of quality of life questionaire

  5. Observational Variables - Long term surveillance [ Time Frame: 2, 3, 4 and 5 years ]
    Clinical change of pulmonary arterial hypertension condition defined by patient survival or cause of mortality

  6. Observational Variables - Long term surveillance [ Time Frame: 2, 3, 4 and 5 years ]
    Clinical change of pulmonary arterial hypertension condition defined by hospitalization due to pulmonary arterial hypertension

  7. Observational Variables - Long term surveillance [ Time Frame: 2, 3, 4 and 5 years ]
    Clinical change of pulmonary arterial hypertension condition defined by any intervention or surgical procedures the patient did

  8. Observational Variables - Long term surveillance [ Time Frame: 2, 3, 4 and 5 years ]
    Clinical change of pulmonary arterial hypertension condition defined by worsening of WHO functional class

  9. Observational Variables - Long term surveillance [ Time Frame: 2, 3, 4 and 5 years ]
    Clinical change of pulmonary arterial hypertension condition defined by escalation of drug therapy

  10. Observational Variables [ Time Frame: 12 month ]
    Echocardiography parameters



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835950


Contacts
Contact: Michal Shohat, DMD +972-54-8030015 info@sonivie.com

Locations
United States, California
UC San Diego Health Recruiting
San Diego, California, United States, 92103
Contact: Hyong (Nick) Kim, MD       h33kim@ucsd.edu   
Principal Investigator: Hyong (Nick) Kim, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Vallerie Mclaughlin, MD       vmclaugh@med.umich.edu   
Principal Investigator: Vallerie Mclaughlin, MD         
United States, New York
Columbia University Medical Center/NewYork Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Erika Berman-Rosenzweig, MD       esb14@cumc.columbia.edu   
Principal Investigator: Erika Berman-Rosenzweig, MD         
United States, Texas
UT Southwestren Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kelly Chin, MD    214-645-5989    Kelly.chin@utsouthwestern.edu   
Principal Investigator: Kelly Chin, MD         
Sponsors and Collaborators
SoniVie Ltd.

Responsible Party: SoniVie Ltd.
ClinicalTrials.gov Identifier: NCT02835950     History of Changes
Other Study ID Numbers: CLNS01-001 USA
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases