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TReatment of Pulmonary Hypertension Group II Study (TROPHY-II)

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ClinicalTrials.gov Identifier: NCT03611270
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
SoniVie Ltd.

Brief Summary:

The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life.

This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR>3 wood units.


Condition or disease Intervention/treatment Phase
Pulmonary Hypertension (PH) Due to Left Heart Disease Device: Pulmonary Denervation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
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 in Patients With Pulmonary Hypertension Due to Left Heart Disease
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Pulmonary Denervation
    Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary 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.


Primary Outcome Measures :
  1. Procedural related Adverse Events (complications) at up to 30 days post procedure [ Time Frame: 30 days ]
    Procedural related Adverse Events (complications) at up to 30 days post procedure including pulmonary artery perforation/dissection, acute thrombus formation in the pulmonary artery, pulmonary artery aneurysm, vascular stenosis, hemoptysis, all cause PH related as well as procedural related death.


Secondary Outcome Measures :
  1. Changes in cardiopulmonary exercise test [ Time Frame: 4 month ]
    Changes in cardiopulmonary exercise test (CPET) results (Peak VO2, VE/VCO2 slope, VO2 at anaerobic threshold, peak workload) from baseline

  2. Change in resting mean right atrial pressure [ Time Frame: 4 month ]
    Change in resting mean atrial pressure (mRAP) from baseline

  3. Changes in 6MWD from baseline [ Time Frame: 4 month ]
    Changes in 6MWD from baseline

  4. Changes in Echocardiography parameters [ Time Frame: 4 month ]
    Changes in Echocardiography parameters including Right Ventricular function from baseline

  5. Change in NT-BNP levels [ Time Frame: 4 month ]
    Change in NT-BNP levels from baseline

  6. Procedure related and PH worsening adverse events [ Time Frame: 12 month ]
    Procedure related and PH worsening adverse events and all cause death up to 12 months will be recorded, and serious adverse events will be reported in accordance with regulatory requirements.

  7. Change in exercise mean right atrial pressure [ Time Frame: 4 month ]
    Change in exercise mean right atrial pressure (mRAP) from baseline

  8. Change in exercise mean pulmonary artery pressure [ Time Frame: 4 month ]
    Change in exercise mean pulmonary artery pressure (mPAP) from baseline

  9. Change in exercise pulmonary vascular resistance [ Time Frame: 4 month ]
    Change in exercise pulmonary vascular resistance (PVR) from baseline

  10. Change in exercise cardiac index [ Time Frame: 4 month ]
    Change in exercise cardiac index (CI) from baseline

  11. Change in resting mean pulmonary artery pressure [ Time Frame: 4 month ]
    Change in resting mean pulmonary artery pressure (mPAP) from baseline

  12. Change in resting pulmonary vascular resistance [ Time Frame: 4 month ]
    Change in resting pulmonary vascular resistance (PVR) from baseline

  13. Change in resting cardiac index [ Time Frame: 4 month ]
    Change in resting cardiac index (CI) from baseline



Information from the National Library of Medicine

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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:

  • Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
  • Male or female, ≥ 18 years of age at the time of screening
  • Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
  • Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
  • Patient with a current diagnosis of NYHA functional class II/III
  • Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150μmol/l

Exclusion Criteria:

  • 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 experiencing a current episode of acute decompensated heart failure
  • Patient who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrolment. Patient who has implantable Cardiomems device, neurostimulators or drug infusion devices, regardless of implant date.

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): NCT03611270


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

Locations
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United States, California
UC San Diego Medical Center Not yet recruiting
San Diego, California, United States, 92037
Contact: Eric Adler, MD    858-657-8530    eradler@ucsd.edu   
Principal Investigator: Eric Adler, MD         
University of California, San Francisco Medical Center Not yet recruiting
San Francisco, California, United States, 94158
Contact: Teresa De Marco, MD    415-476-5148    Teresa.DeMarco@ucsf.edu   
Principal Investigator: Teresa De Marco, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114-2696
Contact: Gregory Lewis, MD    617-724-9254    GLEWIS@PARTNERS.ORG   
Principal Investigator: Gregory Lewis, MD         
Sponsors and Collaborators
SoniVie Ltd.

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Responsible Party: SoniVie Ltd.
ClinicalTrials.gov Identifier: NCT03611270     History of Changes
Other Study ID Numbers: CLNS02-001
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Hypertension
Heart Diseases
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases