TReatment of Pulmonary Hypertension Group II Study



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:November 30, 2018
End Date:July 2020
Contact:Dalit Shav, PhD
Email:info@SoniVie.com
Phone:+97237163152

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Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Hypertension Due to Left Heart Disease

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.


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.
We found this trial at
3
sites
San Diego, California 92103
Principal Investigator: Eric Adler, MD
Phone: 858-657-8530
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Gregory Lewis, MD
Phone: 617-724-9254
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
Principal Investigator: Teresa De Marco, MD
Phone: 415-476-5148
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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