TReatment of Pulmonary Hypertension Group II Study (NCT03611270) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
TReatment of Pulmonary Hypertension Group II Study
United States15 participantsStarted 2018-11-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 previo…
What they're measuring
1
Procedural related Adverse Events (complications) at up to 30 days post procedure