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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02835950
Recruitment Status : Active, not recruiting
First Posted : July 18, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
SoniVie Ltd.

Tracking Information
First Submitted Date  ICMJE July 10, 2016
First Posted Date  ICMJE July 18, 2016
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • Amount of all procedural related adverse event as assessed by the CEC [ Time Frame: 1 month ]
    Procedural related Adverse Events
  • Amount of treatment related adverse event as assessed by the CEC [ Time Frame: 12 month ]
    All treatment related adverse events
  • Number of patient with PAH worsening and all cause death events [ Time Frame: 12 month ]
    PAH related adverse events and all cause death
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02835950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2017)
  • Clinical effectiveness [ Time Frame: 6 months ]
    Changes from baseline of mean pulmonary arterial pressure (mPAP)
  • Clinical effectiveness [ Time Frame: 6 months ]
    Changes from baseline of pulmonary vascular resistance (PVR)
  • Clinical effectiveness [ Time Frame: 6 months ]
    Changes from baseline of 6 minute walking distance (6MWD)
  • Clinical effectiveness [ Time Frame: 6 months ]
    Changes from baseline of quality of life questionaire
  • Clinical effectiveness [ Time Frame: 1, 6 and 12 months ]
    NT-pro-BNP levels
  • Clinical efffectivness [ Time Frame: 6 months ]
    Change from baseline in Right Ventricular (RV) function as assesed by MRI
  • Clinical efffectivness [ Time Frame: 6 months ]
    Change from baseline in Right Ventricular (RV) function as assesed by Echocardiography
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • Clinical effectiveness [ Time Frame: 4 months ]
    Changes from baseline of mean pulmonary arterial pressure (mPAP)
  • Clinical effectiveness [ Time Frame: 4 months ]
    Changes from baseline of pulmonary vascular resistance (PVR)
  • Clinical effectiveness [ Time Frame: 4 months ]
    Changes from baseline of 6 minute walking distance (6MWD)
  • Clinical effectiveness [ Time Frame: 4 months ]
    Changes from baseline of quality of life questionaire
  • Clinical effectiveness [ Time Frame: 1,4,8 and 12 months ]
    NT-pro-BNP levels
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2017)
  • Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of mean pulmonary arterial pressure (mPAP)
  • Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of pulmonary vascular resistance (PVR)
  • Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of 6 minute walking distance (6MWD)
  • Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of quality of life questionaire
  • 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
  • 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
  • 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
  • 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
  • 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
  • Observational Variables [ Time Frame: 12 month ]
    Echocardiography parameters
Original Other Pre-specified Outcome Measures
 (submitted: July 13, 2016)
  • Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of mean pulmonary arterial pressure (mPAP)
  • Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of pulmonary vascular resistance (PVR)
  • Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of 6 minute walking distance (6MWD)
  • Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of quality of life questionaire
  • Observational Variables - Long term surveillance [ Time Frame: 12 Months ]
    Clinical change of pulmonary arterial hypertension condition defined by patient survival or cause of mortality
  • Observational Variables - Long term surveillance [ Time Frame: 12 Months ]
    Clinical change of pulmonary arterial hypertension condition defined by hospitalization due to pulmonary arterial hypertension
  • Observational Variables - Long term surveillance [ Time Frame: 12 Months ]
    Clinical change of pulmonary arterial hypertension condition defined by any intervention or surgical procedures the patient did
  • Observational Variables - Long term surveillance [ Time Frame: 12 Months ]
    Clinical change of pulmonary arterial hypertension condition defined by worsening of WHO functional class
  • Observational Variables - Long term surveillance [ Time Frame: 12 Months ]
    Clinical change of pulmonary arterial hypertension condition defined by escalation of drug therapy
 
Descriptive Information
Brief Title  ICMJE TReatment Of Pulmonary HYpertension 1-US Study
Official Title  ICMJE Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE 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™
Study Arms  ICMJE 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.
Intervention: Device: Therapeutic Intra-Vascular UltraSound (TIVUS™) System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02835950
Other Study ID Numbers  ICMJE CLNS01-001 USA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SoniVie Ltd.
Study Sponsor  ICMJE SoniVie Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SoniVie Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP