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TReatment Of Pulmonary HYpertension 1 Study (TROPHY)

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: NCT02516722
Recruitment Status : Active, not recruiting
First Posted : August 6, 2015
Last Update Posted : April 5, 2019
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 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.

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

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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
Study Start Date : February 2016
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : September 2020


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.





Primary Outcome Measures :
  1. Safety evaluation of the PDN procedure (Procedural related Adverse Events) [ Time Frame: 1 month ]
    Procedural related Adverse Events

  2. Safety evaluation of the PDN procedure (PAH related adverse events and all cause death) [ Time Frame: 12 month ]
    PAH related adverse events and all cause death


Secondary Outcome Measures :
  1. Clinical effectiveness [ Time Frame: 4 months ]
    Changes from baseline of mean pulmonary arterial pressure (mPAP)

  2. Clinical effectiveness [ Time Frame: 4 months ]
    Changes from baseline of pulmonary vascular resistance (PVR)

  3. Clinical effectiveness [ Time Frame: 4 months ]
    Changes from baseline of 6 minute walking distance (6MWD)

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


Other Outcome Measures:
  1. Observational Variables [ Time Frame: 12 Months ]
    Changes from baseline of Nt-pro-BNP

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

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

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

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

  6. Observational Variables - Long term surveillance [ Time Frame: 3 years ]
    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



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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), 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

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): NCT02516722


Locations
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Belgium
Hôpital Erasme
Bruxelles, Belgium
Israel
Kaplan Hospital
Rehovot, Israel
United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Royal Hallamshire Hospital,
Sheffield, United Kingdom
Sponsors and Collaborators
SoniVie Ltd.

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Responsible Party: SoniVie Ltd.
ClinicalTrials.gov Identifier: NCT02516722     History of Changes
Other Study ID Numbers: CLNS01-001
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases