TReatment of Pulmonary Hypertension Group II Study

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03611270
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

SoniVie Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension (PH) Due to Left Heart Disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC San Diego Medical Center, San Diego, California

Status

Not yet recruiting

Address

UC San Diego Medical Center

San Diego, California, 92037

Site Contact

Eric Adler, MD

eradler@ucsd.edu

858-657-8530

San Francisco, California

Status

Recruiting

Address

University of California, San Francisco Medical Center

San Francisco, California, 94158

Site Contact

Richard Cheng, MD

Richard.Cheng@ucsf.edu

+97237163152

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696

Site Contact

Gregory Lewis, MD

GLEWIS@PARTNERS.ORG

617-724-9254

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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