Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114-2696
Contact:
Gregory Lewis, MD
617-724-9254
GLEWIS@PARTNERS.ORG

More Details

NCT ID
NCT03611270
Status
Recruiting
Sponsor
SoniVie Ltd.

Study Contact

Dalit Shav, PhD
+97237163152
info@SoniVie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.