TReatment Of Pulmonary HYpertension 1-US Study

NCT02835950 | Unknown DMC FDA Device

• 1 other identifier: CLNS01-001 USA
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (3)

• Amount of all procedural related adverse event as assessed by the CEC

  Procedural related Adverse Events

  1 month

• Amount of treatment related adverse event as assessed by the CEC

  All treatment related adverse events

  12 month

• Number of patient with PAH worsening and all cause death events

  PAH related adverse events and all cause death

  12 month

Secondary Outcomes (7)

• Clinical effectiveness

  6 months

• Clinical effectiveness

  6 months

• Clinical effectiveness

  6 months

• Clinical effectiveness

  6 months

• Clinical effectiveness

  1, 6 and 12 months

Other Outcomes (10)

• Observational Variables

  12 Months

• Observational Variables

  12 Months

• Observational Variables

  12 Months

Study Arms (1)

Pulmonary Denervation

EXPERIMENTAL

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

Interventions

Therapeutic Intra-Vascular UltraSound (TIVUS™) System DEVICE

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.

Also known as: TIVUS™

Pulmonary Denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SoniVie Inc.: lead

Study Sites (4)

UC San Diego Health

San Diego, California, 92103, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Columbia University Medical Center/NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

UT Southwestren Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2016
• First Posted: July 18, 2016
• Study Start: March 1, 2017
• Primary Completion: April 20, 2019
• Study Completion: December 1, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)