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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Procedural related Adverse Events (complications) at up to 30 days post procedure