Trials / Unknown
UnknownNCT02516722
TReatment Of Pulmonary HYpertension 1 Study
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- SoniVie Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2018-10-01
- Completion
- 2021-06-01
- First posted
- 2015-08-06
- Last updated
- 2021-03-16
Locations
4 sites across 3 countries: Belgium, Israel, United Kingdom
Source: ClinicalTrials.gov record NCT02516722. Inclusion in this directory is not an endorsement.