TReatment of Pulmonary Hypertension Group II Study (TROPHY-II)

SoniVie

Status

Active, not recruiting

Conditions

Pulmonary Hypertension (PH) Due to Left Heart Disease

Treatments

Device: Pulmonary Denervation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03611270

CLNS02-001

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.