Clinical trial NCT03611270: TReatment of Pulmonary Hypertension Group II Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Hypertension (PH) Due to Left Heart Disease
Lead sponsor: SoniVie Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Procedural related Adverse Events (complications) at up to 30 days post procedure
timeFrame: 30 days
Secondary outcomes:
measure: Changes in cardiopulmonary exercise test
timeFrame: 4 month
measure: Change in resting mean right atrial pressure
timeFrame: 4 month
measure: Changes in 6MWD from baseline
timeFrame: 4 month
measure: Changes in Echocardiography parameters
timeFrame: 4 month
measure: Change in NT-BNP levels
timeFrame: 4 month
measure: Procedure related and PH worsening adverse events
timeFrame: 12 month
measure: Change in exercise mean right atrial pressure
timeFrame: 4 month
measure: Change in exercise mean pulmonary artery pressure
timeFrame: 4 month
measure: Change in exercise pulmonary vascular resistance
timeFrame: 4 month
measure: Change in exercise cardiac index
timeFrame: 4 month
measure: Change in resting mean pulmonary artery pressure
timeFrame: 4 month
measure: Change in resting pulmonary vascular resistance
timeFrame: 4 month
measure: Change in resting cardiac index
timeFrame: 4 month
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: